NCT04646733

Effect of a Low-carbohydrate, High-protein Energy-restricted Diet on Weight and Body Composition Using DXA

Completed NA Last updated 19 December 2023

What this trial tests

NA trial testing High Protein Diet Group in Weight Loss in 150 participants. Completed in 30 July 2021.

Timeline

13 January 2020

Primary endpoint
9 May 2020

30 July 2021

Quick facts

Lead sponsor	Erik Ramirez Lopez
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	13 January 2020
Primary completion	9 May 2020
Estimated completion	30 July 2021
Sites	1 location across Mexico

Drugs / interventions tested

• High Protein Diet Group
• No High Protein Diet Group

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Body Composition — all drugs for Body Composition →

Sponsor

Erik Ramirez Lopez

Who can join

Adults 20 to 33, any sex, with Weight Loss or Body Composition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.