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

NCT02278757 | Completed DMC

• 1 other identifier: 120-6707
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X; Weight Loss

Keywords

Metabolic syndrome; Weight loss; Obesity; Hypertension; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Changes in body weight (weight loss)

  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)

  Six months

Study Arms (2)

Low protein diet (LPD)

PLACEBO COMPARATOR

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

High protein diet (HPD)

EXPERIMENTAL

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

Interventions

High protein diet OTHER

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).

Also known as: Intervention group

High protein diet (HPD)

Low protein diet OTHER

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)

Also known as: Placebo comparator

Low protein diet (LPD)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with metabolic syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Mexican National Institute of Public Health: lead

Study Sites (1)

Mexican National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (1)

• Campos-Nonato I, Hernandez L, Barquera S. Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial. Obes Facts. 2017;10(3):238-251. doi: 10.1159/000471485. Epub 2017 Jun 10.

  PMID: 28601864 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Weight Loss; Obesity; Hypertension; Dyslipidemias

Interventions

Diet, High-Protein; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Simon Barquera, PhD

  Mexican Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Policies and Programs in Nutrition

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 30, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

ME (1)