Overweight and Obesity(RACO)NCT04105192
Effectiveness of a Natural Ingredient on Obesity
A study testing dietary supplement consumption in people with Overweight and Obesity and High Blood Pressure, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, High Blood Pressure
- What is being tested?
- dietary supplement consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects of both sexes with age between 18-65 years.
- Subjects with a body mass index greater than 25 and less than 35.
- Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.
Who cannot join
- Subjects under treatment that may affect body weight.
- Subjects with acute diseases.
- Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease.
- Subjects undergoing major surgery in the last 3 months.
- Subjects who quit smoking in the last 6 months or who intend to quit during the study.
- Subjects with allergies or eating disorders.
Show all 9Show fewer
- Volunteers who are participating in another study that includes blood draws or dietary intervention.
- Pregnant or breastfeeding woman.
- Subjects whose condition does not make them eligible for the study, according to the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial on the Efficacy of a Natural Ingredient in Obesity in Subjects With a BMI Greater Than 25 kg / cm2
randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.
Read the detailed description
The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
- Conditions
- Overweight and Obesity, High Blood Pressure
- Being tested
- dietary supplement consumption
- Medical subject headings
- Overweight, Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement consumptionDietary supplement
Consumption of the product under study for 84 days, plecebo or experimental product
| Study group | Role | What they receive |
|---|---|---|
| experimental group (Lippia citriodora + sabdariffa) | Experimental | Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.
Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. Receives: Dietary Supplement: dietary supplement consumption |
| control group Placebo (sucrose) | Placebo comparator | Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg or Placebo (sucrose) Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. Receives: Dietary Supplement: dietary supplement consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Secondary outcomes (9)
Fat mass
Bioimpedancetry, in grams.
Measured: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Muscle mass
Bioimpedancetry, in grams.
Measured: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Percentage of fat mass
Bioimpedancetry.
Measured: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
blood samples: Glucidal metabolism and lipid metabolism.
BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter
Measured: Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Subjective sensation of product consumption
5-point hedonic scale. There are five points, being 1 I do not like and 5 I like it a lot. A scale will be passed through paper.
Measured: Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
MEASURED WITH ACTIGRAPH wGT3X-BT
Measured: Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study
liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Measured: Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group.
Weight
measured in Kg.
Measured: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).
Height
Measured in cm.
Measured: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Mar 2019
- Primary completion20 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105192
- Sponsor's protocol ID
- UCAMCFE-0010
- Acronym
- (RACO)
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial on the Efficacy of a Natural Ingredient in Obesity in Subjects With a BMI Greater Than 25 kg / cm2
- ClinicalTrials.gov ID
- NCT04105192
- Acronym / sponsor ID
- (RACO) / UCAMCFE-0010
- Conditions
- Overweight and Obesity, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 26 Sep 2019 (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.
randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.
Detailed description
The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group (Lippia citriodora + sabdariffa) | Experimental | Dietary Supplement: dietary supplement consumptionConsumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. |
| control group Placebo (sucrose) | Placebo comparator | Dietary Supplement: dietary supplement consumptionConsumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg or Placebo (sucrose) Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of both sexes with age between 18-65 years.
- Subjects with a body mass index greater than 25 and less than 35.
- Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.
Key exclusion criteria (9 listed)
- Subjects under treatment that may affect body weight.
- Subjects with acute diseases.
- Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease.
- Subjects undergoing major surgery in the last 3 months.
- Subjects who quit smoking in the last 6 months or who intend to quit during the study.
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 |
|---|---|---|
| dietary supplement consumptionConsumption of the product under study for 84 days, plecebo or experimental product | Dietary supplement | control group Placebo (sucrose), experimental group (Lippia citriodora + sabdariffa) |
Primary outcome
Total fat mass
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in torso
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in lower limbs
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
9 secondary outcomes
Fat mass
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Muscle mass
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Percentage of fat mass
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
blood samples: Glucidal metabolism and lipid metabolism.
Time frame: Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Subjective sensation of product consumption
Time frame: Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
Time frame: Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study
liver safety variables
Time frame: Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group.
Weight
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).
Height
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement consumption in people with Overweight and Obesity and High Blood Pressure, run by Universidad Católica San Antonio de Murcia 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 1 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fat mass (time frame: From baseline to 84 days). The study lists 3 primary outcomes in all. 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 1 Apr 2020.