Weight LossNCT02160496
A Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women
A study testing Weight loss interventional study with 20% protein-diet, Weight loss interventional study with 27% protein-diet and Weight loss interventional study with 35% protein-diet in people with Weight Loss and Obesity, run by Instituto Aragones de Ciencias de la Salud.
Trial summary
The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Overweight
- What is being tested?
- Weight loss interventional study with 20% protein-diet, Weight loss interventional study with 27% protein-diet and Weight loss interventional study with 35% protein-diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2014
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old.
- Body mass index between 27.5 - 40.
- Steady weight in last 3 months (±3 kg).
- Informed consent provided.
Who cannot join
- Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- Type 2 diabetes mellitus with bad metabolic control (HbA1c > 8%).
- Lipid-lowering drugs in the last 3 months.
- Intake of functional foods with plant sterols in the past 6 weeks.
- Vitamin supplements intake.
- Hormone replacement therapy.
Show all 10Show fewer
- Consumption of Orlistat in the last 2 months
- High intake of alcohol (> 30 gr./day).
- Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
- Pregnancy or intention of pregnancy during the study.
About this study
Official title: A Randomized Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women
The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.
- Conditions
- Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids
- Being tested
- Weight loss interventional study with 20% protein-diet, Weight loss interventional study with 27% protein-diet, Weight loss interventional study with 35% protein-diet
- Keywords
- Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids
- Medical subject headings
- Weight Loss, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss interventional study with 20% protein-dietBehavioural
Weight loss interventional study with 27% protein-dietBehavioural
Weight loss interventional study with 35% protein-dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 20% protein hypocaloric diet | Active comparator | Participants were advised with a hypocaloric diet with the following composition: 20% protein, 30% fat and 50% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. Receives: Behavioral: Weight loss interventional study with 20% protein-diet |
| 27% protein hypocaloric diet | Active comparator | Participants were advised with a hypocaloric diet with the following composition: 27% protein, 30% fat and 43% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. Receives: Behavioral: Weight loss interventional study with 27% protein-diet |
| 35% protein hypocaloric diet | Active comparator | Participants were advised with a hypocaloric diet with the following composition: 35% protein, 30% fat and 35% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. Receives: Behavioral: Weight loss interventional study with 35% protein-diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..
The main outcome is to study the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from lean red meat, on body weight and lipid profile in overweight and obese women.
Measured: After 3 months of intervention
Secondary outcomes (2)
Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.
Measured: After 3 months of intervention.
Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.
Measured: After 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Civeira, Instituto Aragones de Ciencias de la Salud
- Investigators
- Fernando Civeira, MD, PhD, Principal investigator, Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)Rocio Mateo-Gallego, MSc, Principal investigator, Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160496
- Sponsor's protocol ID
- CEICA;PI13/00108
- Other IDs
- I+CS-HUMS-B80_PI13/00108
- Status last verified
- Nov 2016
- First submitted
- 5 Jun 2014
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedi V, Bea AM, Baila-Rueda L, Laclaustra M, Penalvo JL, Civeira F, Cenarro A. Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):133-142. doi: 10.1016/j.numecd.2017.10.024. Epub 2017 Nov 4.
PubMed 29329923Mateo-Gallego R, Marco-Benedi V, Perez-Calahorra S, Bea AM, Baila-Rueda L, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets. Clin Nutr. 2017 Apr;36(2):371-379. doi: 10.1016/j.clnu.2016.01.018. Epub 2016 Jan 29.
PubMed 26875447
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT02160496
- Acronym / sponsor ID
- CEICA;PI13/00108
- Conditions
- Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids
- Keywords
- Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- 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 objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20% protein hypocaloric diet | Active comparator | Behavioral: Weight loss interventional study with 20% protein-dietParticipants were advised with a hypocaloric diet with the following composition: 20% protein, 30% fat and 50% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
| 27% protein hypocaloric diet | Active comparator | Behavioral: Weight loss interventional study with 27% protein-dietParticipants were advised with a hypocaloric diet with the following composition: 27% protein, 30% fat and 43% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
| 35% protein hypocaloric diet | Active comparator | Behavioral: Weight loss interventional study with 35% protein-dietParticipants were advised with a hypocaloric diet with the following composition: 35% protein, 30% fat and 35% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-80 years old.
- Body mass index between 27.5 - 40.
- Steady weight in last 3 months (±3 kg).
- Informed consent provided.
Key exclusion criteria (10 listed)
- Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- Type 2 diabetes mellitus with bad metabolic control (HbA1c > 8%).
- Lipid-lowering drugs in the last 3 months.
- Intake of functional foods with plant sterols in the past 6 weeks.
- Vitamin supplements intake.
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 |
|---|---|---|
| Weight loss interventional study with 20% protein-diet | Behavioural | 20% protein hypocaloric diet |
| Weight loss interventional study with 27% protein-diet | Behavioural | 27% protein hypocaloric diet |
| Weight loss interventional study with 35% protein-diet | Behavioural | 35% protein hypocaloric diet |
Primary outcome
Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..
Time frame: After 3 months of intervention
The main outcome is to study the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from lean red meat, on body weight and lipid profile in overweight and obese women.
2 secondary outcomes
Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.
Time frame: After 3 months of intervention.
Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.
Time frame: After 3 months of intervention.
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 Dec 2016.
- Derived from this study: PubMed 29329923Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedi V, Bea AM, Baila-Rueda L, Laclaustra M, Penalvo JL, Civeira F, Cenarro A. Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):133-142. doi: 10.1016/j.numecd.2017.10.024. Epub 2017 Nov 4.
- Derived from this study: PubMed 26875447Mateo-Gallego R, Marco-Benedi V, Perez-Calahorra S, Bea AM, Baila-Rueda L, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets. Clin Nutr. 2017 Apr;36(2):371-379. doi: 10.1016/j.clnu.2016.01.018. Epub 2016 Jan 29.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
Fernando Civeira, MD, PhD principal investigator
Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Rocio Mateo-Gallego, MSc principal investigator
Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss interventional study with 20% protein-diet, Weight loss interventional study with 27% protein-diet and Weight loss interventional study with 35% protein-diet in people with Weight Loss and Obesity, run by Instituto Aragones de Ciencias de la Salud.
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 4 inclusion and 10 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (time frame: After 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02160496, which also lists 2 linked publications.
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 Dec 2016.