Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Two Diets With Different Content of Protein on Weight Loss in Adults With Metabolic Syndrome (DPMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278757
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health

Brief Summary:

Randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65 years) with Metabolic Syndrome (MS). The sample size was calculated using a formula that compares two means, an alpha of 0.05 and a power of 95%. Based on these calculations, we established a baseline sample of 118 adults. For the diagnosis of MS, we used the classification from the International Diabetes Federation (IDF). 150 patients were screened; however, 32 were excluded because they did not meet the criteria. Doctors wrote down medical history; nutritionists conducted anthropometry (weight, height, and waist circumference); and nurses measured blood pressure and withdrew venous blood for determination of glucose, triglycerides, and HDL-cholesterol. After being randomly assigned to one of two groups, the control group received a diet with a lower protein content (0.8gr/kg body weight), and the intervention group received a diet with higher protein content (1.34gr/kg body weight). Both diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a caloric restriction of 500 calories less.

For the intervention group, meal replacements were made with soy protein, and individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. Used as a substitute for food, the protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water. For both groups, the calorie density of the diet was adjusted for the baseline metabolic rate of each participant with a restriction of 500kcal/day.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Weight Loss Other: High protein diet Other: Low protein diet Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Enriched Meal Replacements Protein on Weight Loss in Adults With Metabolic Syndrome
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Placebo Comparator: Low protein diet (LPD)
Control group received a diet with a lower protein content (0.8gr/kg body weight). Conventional foods (such as fish, meet, vegetables, fruits, nutrs, beans, etc) were prescribed. Individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. The calorie density had a restriction of 500kcal/day. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week)
Other: Low protein diet
Control group received a diet with a lower protein content (0.8gr/kg body weight). Conventional foods (such as fish, meet, vegetables, fruits, nutrs, beans, etc) were prescribed. Individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. The calorie density had a restriction of 500kcal/day. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week)
Other Name: Placebo comparator

Experimental: High protein diet (HPD)
HPD received a diet with higher protein content (1.34gr/kg body weight). HPD and LPD diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a caloric restriction of 500 calories less than the resting metabolic rate (RMR). Meal replacements (drinks and bars), and individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. Participants consumed two, protein-enriched drinks, contributing to the daily protein intake along with conventional foods and two low-fat bars. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week)
Other: High protein diet
Group received a diet with higher protein content (1.34gr/kg body weight). Meal replacements (drinks and bars) and individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. Participants consumed two, protein-enriched drinks, contributing to the daily protein intake along with conventional foods and two low-fat bars. For both groups (intervention and control), the calorie density had a restriction of 500kcal/day calories less than the resting metabolic rate (RMR) and were equivalent in the type of carbohydrate. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week).
Other Name: Intervention group




Primary Outcome Measures :
  1. Changes in body weight (weight loss) [ Time Frame: Six months ]
    Changes in body weight will be evaluate through measures in baseline (month 0), month 3 (intermediate) and month 6 (final) by an Body weight Analyzer (model Avis 333)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with metabolic syndrome

Exclusion Criteria:

  • Bariatric surgery for weight loss
  • Smoking
  • Use of alcohol or drugs
  • Psychiatric disorders
  • Anti-obesity medication
  • Soy protein intolerance
  • Women not using birth control methods
  • Not pregnant or lactating
  • Body weight gain or loss greater than two percent three months prior to the start of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278757


Locations
Layout table for location information
Mexico
Mexican National Institute of Public Health
Cuernavaca,, Morelos, Mexico, 62100
Sponsors and Collaborators
Mexican National Institute of Public Health
Investigators
Layout table for investigator information
Principal Investigator: Simon Barquera, PhD Mexican Institute of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Simon Barquera, MD, MS, PhD, Director of Policies and Programs in Nutrition, Mexican National Institute of Public Health
ClinicalTrials.gov Identifier: NCT02278757    
Other Study ID Numbers: 120-6707
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health:
Metabolic syndrome
Weight loss
Obesity
Hypertension
Dyslipidemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Syndrome
Body Weight
Weight Loss
Disease
Pathologic Processes
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases