ObesityCOGLUBOCONCT07165548
Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity
A study testing Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction), Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction) and Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction) in people with Obesity and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction), Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction) and Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 20 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes between the ages of 18 and 65 years old.
- Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg/m2).
- Physical examination and vital signs are normal or clinically irrelevant to the study.
- Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation.
- Individuals undergoing treatment for diabetes will be excluded.
- Participants must be capable of understanding the study requirements, willing to provide written informed consent, and able to comply with all study procedures and timelines.
- Body weight must have remained stable (±5%) during the three months preceding study initiation.
Who cannot join
- Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.
- High alcohol consumption, defined as >14 units per week for women and >20 units per week for men.
- Pregnancy or lactation at the time of screening.
- History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).
- Diagnosis of arthritis.
- History of any liver disease, with the exception of non-alcoholic fatty liver disease.
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- Diagnosis of any type of cancer, current cancer treatment, or history of cancer treatment within the past five years.
- Known allergy or hypersensitivity to any component of the investigational product or to any food that could interfere with study participation and follow-up.
- Presence of cognitive and/or psychological impairment that could affect study compliance.
- Anticipated poor adherence or, in the opinion of the investigator, inability to comply with study procedures.
- Engagement in night-shift work.
- Current use of dietary supplements that may interfere with study outcomes (e.g., nutraceuticals containing compounds with potential weight loss effects).
- Ongoing treatment for weight loss or diabetes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Center for Nutrition Research
Pamplona, Navarre, 31008
María Ángeles Zulet, PhD, 948425600 ext. 806317, mazulet@unav.es
About this study
Official title: Evaluation of the Effect of Supplementation With Satiating Compounds Integrated Into a Hypocaloric Diet on Weight and Cardiometabolic and Osteoarticular Health in Overweight/Obese Subjects
The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity.
To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period.
Read more
The main questions to answer are:
- Does the regular consumption of these protein and/or fiber bars help to lose weight?
- Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health?
- Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health?
The specific objectives are focused on evaluating the effects of the intervention on the following parameters:
- Weight and body composition.
- Knee joint range of motion.
- Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health.
- Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health.
- Changes in joint discomfort (improvement or worsening).
- Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement.
- Satiety-related variables assessed using a visual analog scale (VAS).
- Urinary hydroxyproline and stool samples for metagenomic analysis.
- Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires.
Target sample size is 144 subjects and participants will be allocated in four different groups:
- Group 1 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 2 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 3 (n=36): hypocaloric diet + fiber supplement.
- Group 4 "Placebo group" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.
Read the detailed description
Volunteers expressing interest in the study will undergo an initial eligibility assessment, either via telephone interview or by completing an online screening form (Google Form), to verify compliance with the primary inclusion criteria. Candidates meeting these criteria will be invited to attend an information and screening visit, during which the study procedures will be explained in detail and any questions addressed. Individuals who agree to participate will provide written informed consent and will be randomly allocated to one of the four intervention groups. All necessary study materials will be provided at this stage.
Participants will attend three scheduled clinical investigation visits: baseline (day 0), mid-intervention (week 8), and post-intervention (week 12). At each visit, anthropometric and body composition measurements will be performed, and blood pressure will be recorded. Biological samples, including blood, urine, and stool, will be collected. In addition, data regarding dietary intake, physical activity levels, sleep patterns, and gastrointestinal symptoms will be obtained through validated questionnaires.
- Conditions
- Obesity, Overweight
- Being tested
- Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction), Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction), Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction), Placebo Bar + Hypocaloric diet (10% energy restriction)
- Keywords
- Nutritional intervention, Dietary supplement, Protein bar, Fiber bar, Hypocaloric Diet, Obesity, Weight loss, Satiety, Cardiometabolic health, Osteoarticular health, Quality of life
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)Dietary supplement
Participants will consume three satiating compound-enriched bars (formulation 1) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)Dietary supplement
Participants will consume three satiating compound-enriched bars (formulation 2) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)Dietary supplement
Participants will consume three satiating compound-enriched bars (formulation 3) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Placebo Bar + Hypocaloric diet (10% energy restriction)Dietary supplement
Participants will consume three placebo bars daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Bars containing satiating compounds: formulation 1 Receives: Dietary Supplement: Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction) |
| Experimental group 2 | Experimental | Bars containing satiating compounds: formulation 2 Receives: Dietary Supplement: Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction) |
| Experimental group 3 | Experimental | Bars containing satiating compounds: formulation 3 Receives: Dietary Supplement: Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction) |
| Placebo group | Placebo comparator | Placebo bars Receives: Dietary Supplement: Placebo Bar + Hypocaloric diet (10% energy restriction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight of participants will be measured by bioimpedance an densitometry and reported in kg
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Secondary outcomes (66)
Height
Height of participants will be measured by stadiometer and reported in cm.
Measured: Clinical Investigation Day 1
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (m)2
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Neck circumference
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body fat mass
Body fat of participants will be analyzed by bioimpedance and densitometry and reported in percentage and kilograms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body lean mass
Body lean mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fat free mass
Fat free mass of participants will be analyzed by densitometry and reported in kilograms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Visceral fat
Visceral fat of participants will be measured by bioimpedance an densitometry and reported in g.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body water mass
Body water mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms and percentage.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body bone mass
Body bone mass Body bone mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Systolic blood pressure
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Diastolic blood pressure
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Heart rate
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in pulses/min.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total bone mineral density
Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Bone mineral density L1-L4
Bone mineral density L1-L4 of participants will be analyzed by densitometry and reported in g/cm2.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Total bone mineral density femur
Total bone mineral density femur of participants will be analyzed by densitometry and reported in g/cm2.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Bone mineral density femur neck
Bone mineral density femur neck of participants will be analyzed by densitometry and reported in g/cm2.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Knee articular range
Knee articular range of participants will be measured using a goniometer and performing the chair test.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Grip strength
Grip strength of participants will be measured using a manual dynamometer and reported in kg.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Level of hunger
Hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value is 100 mm. A reduction in hunger scale means better outcome.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of fullness
Fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of satisfaction
Satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2
Want to eat something else
Want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2
Thirst
Thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2
Life quality
Life quality of participants will be evaluated by SF-36 questionnaire (36-Item Short Form Survey).
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Depression
Depression will be evaluated using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Anxiety
Anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI), a 40-item self-report questionnaire that includes two subscales: State Anxiety (20 items) and Trait Anxiety (20 items). Each subscale yields scores ranging from 20 to 80, with higher scores indicating greater levels of anxiety.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Osteoarticular health
Osteoarticular health of participants will be measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), a 24-item self-report questionnaire that assesses pain (range 0-20), stiffness (range 0-8), and physical function (range 0-68). The total score ranges from 0 to 96, with higher scores indicating worse osteoarticular symptoms and functional impairment.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Physical activity
Physical activity will be evaluated using the Physical Activity Questionnaire of the Seguimiento Universidad de Navarra (SUN) cohort, which estimates total physical activity expressed in Metabolic Equivalent of Task hours per week (MET-h/week). Higher values indicate greater levels of physical activity. Participants can also be classified into categories of low, moderate, or high physical activity according to standardized SUN cohort scoring procedures.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Glucose concentration
Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Insulin concentration
Blood insulin concentration will be analyzed after an overnight fast by ELISA kit and reported in μUI/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HOMA index (Homeostatic Model Assessment Index)
HOMA index will be calculated as follows: HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)= [fasting glucose (mmol/L) x fasting insulin (μU/ml)] / 22.5.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total cholesterol
Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HDL cholesterol
Blood HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
LDL cholesterol
LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Triglyceride concentration
Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Alanine aminotransferase
Alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Aspartate aminotransferase
Aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Gamma-glutamyl transferase
Gamma-glutamyl transferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fatty liver Index (FLI)
Fatty liver Index will be calculated as follows FLI = (e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745)/ (1 + e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745) × 100
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fructosamine concentration
Blood fructosamine concentration will be analyzed after an overnight fast by ELISA kit and reported in µg/L.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Leptine
Blood leptine concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/ml
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Adiponectin
Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Homocysteine
Blood homocysteine concentration will be analyzed after an overnight fast by biochemical autoanalyzer and reported in μmol/L.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
MCP1 (Monocyte Chemoattractant Protein-1)
Blood MCP1 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
TNF-alpha (tumor necrosis factor alpha)
TNF-alpha will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Interleukin 6 (IL6)
Blood IL6 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
C Reactive protein (CRP)
Blood CRP concentration will be analyzed after an overnight fast by ELISA kit and reported in mg/L
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Blood glycated hemoglobin
Fasting blood glycated hemoglobin will be reported in percentage.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Plasma CTX-II levels (C-terminal telopeptide of type II collagen)
Plasma CTX-II levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Plasma C2C levels (Cartilage Collagen Neoepitope)
Plasma C2C levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Plasma CP2 levels (type II procollagen carboxy-propeptide)
Plasma CP2 levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Albumin concentration
Albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg/dl.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Creatinine concentration
Creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg/dl.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Hydroxyproline
Urine hydroxyproline concentration will be analyzed after an overnight fast by colorimetry technique and reported in mg/ml.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Blood untargeted metabolomics
Untargeted metabolites will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Urine untargeted metabolomics
Untargeted metabolomics will be expressed and analyzed in urine according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Lipidomic
Lipidomic will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Dietary Intake (Energy and Nutrients)
Dietary intake will be assessed using the Food Frequency Questionnaire (FFQ). Outcomes will include energy intake (kcal/day), macronutrient intake (g/day), and micronutrient intake (mg/day or µg/day).
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Mediterranean Diet Adherence
Adherence to the Mediterranean dietary pattern will be evaluated using the Mediterranean Diet Adherence Questionnaire, with scores ranging from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean diet.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Snacking frequency
Snacking behavior will be recorded using a daily snacking record. Results will be expressed as number of snacks per day.
Measured: Clinical Investigation Day 1, Clinical Investigation Day 2, and Clinical Investigation Day 3
Adherence to bars consumption
Adherence will be assessed using the bars consumption record form.
Measured: Clinical Investigation Day 2 and Clinical Investigation Day 3
Acceptance of bars
Acceptance will be assessed using the acceptance consumption record form.
Measured: Clinical Investigation Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Aug 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 parallel groups, 12-week, randomized nutritional intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Ángeles Zulet, PhD, Principal investigator, Center for Nutrition ResearchFermín Milagro, PhD, Study chair, Center for Nutrition ResearchIdoia Ibero, Study chair, Center for Nutrition ResearchMaría Hernández, Study chair, Center for Nutrition ResearchMiguel López, PhD, Study chair, Center for Nutrition ResearchVerónica Ciaurriz, Study chair, Center for Nutrition ResearchCarlos J González, PhD, Study chair, Center for Nutrition ResearchSalomé Pérez, Study chair, Center for Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165548
- Sponsor's protocol ID
- COGLUBOCO (2025.116)
- Acronym
- COGLUBOCO
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Supplementation With Satiating Compounds Integrated Into a Hypocaloric Diet on Weight and Cardiometabolic and Osteoarticular Health in Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT07165548
- Acronym / sponsor ID
- COGLUBOCO / COGLUBOCO (2025.116)
- Conditions
- Obesity, Overweight
- Keywords
- Nutritional intervention, Dietary supplement, Protein bar, Fiber bar, Hypocaloric Diet, Obesity, Weight loss, Satiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity.
To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period.
The main questions to answer are:
- Does the regular consumption of these protein and/or fiber bars help to lose weight?
- Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health?
- Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health?
The specific objectives are focused on evaluating the effects of the intervention on the following parameters:
- Weight and body composition.
- Knee joint range of motion.
- Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health.
- Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health.
- Changes in joint discomfort (improvement or worsening).
- Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement.
- Satiety-related variables assessed using a visual analog scale (VAS).
- Urinary hydroxyproline and stool samples for metagenomic analysis.
- Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires.
Target sample size is 144 subjects and participants will be allocated in four different groups:
- Group 1 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 2 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 3 (n=36): hypocaloric diet + fiber supplement.
- Group 4 "Placebo group" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.
Detailed description
Volunteers expressing interest in the study will undergo an initial eligibility assessment, either via telephone interview or by completing an online screening form (Google Form), to verify compliance with the primary inclusion criteria. Candidates meeting these criteria will be invited to attend an information and screening visit, during which the study procedures will be explained in detail and any questions addressed. Individuals who agree to participate will provide written informed consent and will be randomly allocated to one of the four intervention groups. All necessary study materials will be provided at this stage.
Participants will attend three scheduled clinical investigation visits: baseline (day 0), mid-intervention (week 8), and post-intervention (week 12). At each visit, anthropometric and body composition measurements will be performed, and blood pressure will be recorded. Biological samples, including blood, urine, and stool, will be collected. In addition, data regarding dietary intake, physical activity levels, sleep patterns, and gastrointestinal symptoms will be obtained through validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 parallel groups, 12-week, randomized nutritional intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Dietary Supplement: Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)Bars containing satiating compounds: formulation 1 |
| Experimental group 2 | Experimental | Dietary Supplement: Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)Bars containing satiating compounds: formulation 2 |
| Experimental group 3 | Experimental | Dietary Supplement: Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)Bars containing satiating compounds: formulation 3 |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo Bar + Hypocaloric diet (10% energy restriction)Placebo bars |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteers of both sexes between the ages of 18 and 65 years old.
- Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg/m2).
- Physical examination and vital signs are normal or clinically irrelevant to the study.
- Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation.
- Individuals undergoing treatment for diabetes will be excluded.
Key exclusion criteria (13 listed)
- Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.
- High alcohol consumption, defined as >14 units per week for women and >20 units per week for men.
- Pregnancy or lactation at the time of screening.
- History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).
- Diagnosis of arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)Participants will consume three satiating compound-enriched bars (formulation 1) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks. | Dietary supplement | Experimental group 1 |
| Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)Participants will consume three satiating compound-enriched bars (formulation 2) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks. | Dietary supplement | Experimental group 2 |
| Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)Participants will consume three satiating compound-enriched bars (formulation 3) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks. | Dietary supplement | Experimental group 3 |
| Placebo Bar + Hypocaloric diet (10% energy restriction)Participants will consume three placebo bars daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks. | Dietary supplement | Placebo group |
Primary outcome
Body weight
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Weight of participants will be measured by bioimpedance an densitometry and reported in kg
66 secondary outcomes
Height
Time frame: Clinical Investigation Day 1
Body mass index
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Waist circumference
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Hip circumference
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Neck circumference
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body fat mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body lean mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body muscle mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fat free mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Visceral fat
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body water mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body bone mass
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Systolic blood pressure
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Diastolic blood pressure
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Heart rate
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total bone mineral density
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Bone mineral density L1-L4
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Total bone mineral density femur
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Bone mineral density femur neck
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Knee articular range
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Grip strength
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Level of hunger
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of fullness
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of satisfaction
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Want to eat something else
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Thirst
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Life quality
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Depression
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Anxiety
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Osteoarticular health
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Physical activity
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Gastrointestinal symptoms
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Glucose concentration
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Insulin concentration
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HOMA index (Homeostatic Model Assessment Index)
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total cholesterol
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HDL cholesterol
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
LDL cholesterol
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Triglyceride concentration
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Alanine aminotransferase
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Ángeles Zulet, PhD principal investigator
Center for Nutrition Research
Fermín Milagro, PhD study chair
Center for Nutrition Research
Idoia Ibero study chair
Center for Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction), Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction) and Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction) in people with Obesity and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Ángeles Zulet, PhD (+34948425600 ext. 806317, mazulet@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.