Effect of Two Diets With Different Content of Protein on Weight Loss in Adults With Metabolic Syndrome (DPMS)
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|ClinicalTrials.gov Identifier: NCT02278757|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : March 16, 2016
|First Submitted Date ICMJE||October 27, 2014|
|First Posted Date ICMJE||October 30, 2014|
|Last Update Posted Date||March 16, 2016|
|Study Start Date ICMJE||January 2014|
|Actual Primary Completion Date||January 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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)
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Effect of Two Diets With Different Content of Protein on Weight Loss in Adults With Metabolic Syndrome|
|Official Title ICMJE||Effect of Enriched Meal Replacements Protein on Weight Loss in Adults With Metabolic Syndrome|
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.
Our study was a randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65 years) with Metabolic Syndrome (MS). The individuals were invited to participate from posters and social network advertising. The study was conducted in two Mexican clinics (Mexico City and Cuernavaca) for obesity and metabolic disorders, used by the Mexican National Institute of Public Health (INSP) as recruitment centers. 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), and therefore participants were required to have three or more of the following criteria: a) waist circumference ≥90 cm in men and ≥80 cm in women, b) triglycerides ≥150 mg/dL, c) high density lipoprotein (HDL-cholesterol) <40 mg/dL in men and <50 mg/dL in women, d) blood pressure ≥130/85 mmHg; and e) fasting glucose ≥100 mg/dL. Exclusion criteria included 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, and not pregnant or lactating, and body weight gain or loss greater than two percent three months prior to the start of the study. To achieve the baseline sample of 118 adults, 150 patients were screened; however, 32 were excluded because they did not meet the criteria.
During screening, individuals interested in participating received an explanation of the study design and were given sufficient time to consider inclusion in the clinical trial and complete the form for informed consent. On the same day as consent, 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 the medical evaluation and nutritional status, we provided meal replacements enriched with soy protein that were consumed during the following two days, testing soy protein tolerance. Each clinic supervisor enrolled participants, and the study coordinator conducted the randomization sequencing and assigned participants to interventions.
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 than the resting metabolic rate (RMR) based on the Harris-Benedict´s formula. The overall study design is shown in Figure 1.
For the intervention group, meal replacements (drinks and bars) were made with soy protein, and indivi-dualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily.
After randomization (week 0), participants received specific diet instructions. Each month, diets contained 15 different options and were sufficient to meet the needs of micronutrients recommended by the US Institute of Medicine (recommended dietary intake) according to age and sex.
In the intervention group, participants consumed two, protein-enriched drinks, contributing to the daily protein intake (1.34g protein/kg body weight) along with conventional foods and two low-fat bars. Used as a substitute for food, the protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water. The nutritional contents of the protein-enriched drink with milk contained 145 calories, 9g protein, 3g fat, and 20.5g carbohydrates. For water, the nutritional contents of the protein-enriched drink contained 22 calories, 5g protein, 0.2g fat, and 0g carbohydrates. In the control group, participants ate three meals and two snacks to have a daily intake of 0.8g protein/kg body weight. 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.
Measurements Previously trained on standards for procedure, nutritionists completed monthly documentation of food frequency questionnaires for participants´ total caloric intake and grams of protein consumed per day. To minimize errors, the nutritionists and participants scrutinized and discussed the food diaries. The nutritionists also conducted anthropometry (weight and waist circumference) at baseline and at three and six months, using internationally recognized techniques. The weight and body composition was measured by an Analyzer Avis 333, and the waist circumference was measured with a tape measure, using the line between the lower costal border and the iliac crest as reference points. At baseline, height was measured with a wall stadiometer (SECA Model 222) with an accuracy of 0.1cm. Body mass index (BMI) was calculated as weight/height 2.
Nurses measured blood pressure after 10 minutes of rest with a digital sphygmomanometer (OMRON HEM-907), following the recommendations of the American Heart Association. Blood samples were drawn after a 9- to 12-hour fasting and processed without delay. Laboratory testing included results for metabolic syndrome and HDL-cholesterol, insulin, hemoglobin A1c (HbA1c), C-reactive protein (CRP), direct bilirubin and indirect bilirubin. All measurements were performed at the Mexican National Institute of Public Health (INSP). A previously validated questionnaire was used to evaluate adherence to study recommendations for diet and exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week).
STATISTICAL ANALYSIS The results were shown for the baseline as mean ± standard deviation; and for the comparison between baseline to 6 months as absolute changes or percentage of weight loss. We used the analysis of variance (ANOVA) for means and X2 test for percentages to compare the two groups overtime. Two strategies were used to analyze the data: 1) all participants who completed the study after six months, and 2) those participants who dropped out of the study between baseline and six months, using the last recorded measure-ment.
The analysis of percentage of weight loss between baseline and 6 months we adjusted for adherence to study recommendations. For this analysis, only the participants who adhered to a minimum of 75% of the study design recommendations were considered. Statistical calculations were performed using the STATA program version 13.
Ethical and biosecurity This study was approved by the ethics, research, and biosafety committees from the INSP. Written informed consent was obtained from all participants. All researchers participated in an ethics certification course, "Human Participants Protection Education for Research Teams", given by the US National Institutes of Health (NIH).
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Study Arms ICMJE||
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Actual Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||March 2015|
|Actual Primary Completion Date||January 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||20 Years to 65 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Mexico|
|Removed Location Countries|
|NCT Number ICMJE||NCT02278757|
|Other Study ID Numbers ICMJE||120-6707|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health|
|Study Sponsor ICMJE||Mexican National Institute of Public Health|
|Collaborators ICMJE||Not Provided|
|PRS Account||Mexican National Institute of Public Health|
|Verification Date||March 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP