Effect of a Low-carbohydrate, High-protein Energy-restricted Diet on Weight and Body Composition Using DXA
NCT04646733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-12-19
Summary
People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. However, this diet is aggressive in its first phase because it suppresses carbohydrates, the main source of external energy being saturated low-fat protein. Studies of this diet are scarce and have been limited to describing the contribution of micronutrients. In nutritional practice, it is often assumed that a popular high-protein or low-calorie ketogenic diet could cause rapid or unfavourable changes in a patient's weight and body composition. However, the effect of these diets in the short or long term on weight and on body fat, muscle mass and other components is not clear. This means that body composition has not been the main objective when analyzing the effect of a popular diet. For this reason, the meta-analyzes focus on weight change and the absence of body composition data is a limitation of the selected studies. Changes in body composition due to a popular diet should be evaluated with techniques such as DXA. The aim of this study is to analyze the effect of a low-carbohydrate, high-protein diet with energy restriction on weight and body composition using DXA. For this, a randomized controlled study will be used where a group will receive the diet protocol. The control group will have a normal diet, and only one oatmeal drink will be added (55 g of oats in 250 ml of water). The drink will contain 1.6 g of BetaG per serving according to FDA recommendations that correspond to the 50% BetaG required per day.
Conditions
- Weight Loss
- Body Composition
Interventions
- OTHER
-
High Protein Diet Group
The high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. This diet has 4 phases, two of weight loss until reaching the ideal weight (attack and cruise) and two of maintenance (consolidation and stabilization). During the first 2 phases, it allows 100 foods (28 vegetables). The first phase lasts 3-10 days and 72 high-protein, low-fat foods are allowed. In the second phase, there are alternate days between consuming the low glycemic index vegetables plus protein and the next day with just protein. The first two phases are ad libitum. Phase 3 (consolidation) aims to avoid rebound and begins the introduction of complex carbohydrates and legumes in individual servings. In phase 4 (stabilization), the subject returns to a free diet. However, three basic rules are introduced: protein one day a week, the exercise of at least 20 min/day (optional) and consumption of 3 tablespoons of oat bran/day.
- OTHER
-
No High Protein Diet Group
No high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. Beverage contained 1.6 g of betaG per portion according to FDA recommendations corresponding to 50 % of betaG required per day. Weekly bags containing oat mixture were provided on day 0 and in the third week of the trial. No additional instructions about diet, exercise program or pharmacological treatment was implemented.
Sponsors & Collaborators
-
Erik Ramirez Lopez
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 33 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-01-13
- Primary Completion
- 2020-05-09
- Completion
- 2021-07-30
Countries
- Mexico
Study Locations
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