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

NCT04646733 | Completed

• 2 other identifiers: erik2020DUKANREPRIN-FOD-76
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Body fat

  Body fat measurements by DXA

  Baseline to three months.

• Lean mass

  Lean mass measurements by DXA

  Baseline to three months

• Weight lost

  Weight lost through the various phases

  Baseline to three months

Secondary Outcomes (14)

• Body water

  Baseline to three months

• Resting energy expenditure

  Baseline to three months

• Caloric and macronutrient intake

  Baseline to three months

• Serum fasting triglycerides

  Baseline to three months

• Serum fasting glucose

  Baseline to three months

Study Arms (2)

High Protein Diet Group

EXPERIMENTAL

The high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet.

Other: High Protein Diet Group

No High Protein Diet Group

ACTIVE COMPARATOR

No high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water.

Other: No High Protein Diet Group

Interventions

High Protein Diet Group OTHER

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.

High Protein Diet Group

No High Protein Diet Group OTHER

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.

No High Protein Diet Group

Eligibility Criteria

• Age: 20 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• individuals between the ages of 20 and 30
• who were not currently consuming any drugs or were on diet or exercise treatment.
• patients must have 120% or more of the ideal weight until a BMI of 35.

You may not qualify if:

• with no cardiovascular disease, kidney, intestinal or liver disease.
• cholesterol (≥ 200 mg/dL)
• high triglycerides (≥ 150mg/dL)
• glucose (≥ 126mg /dL)

Sponsors & Collaborators

• Erik Ramirez Lopez: lead

Study Sites (1)

Facultad de Organización Deportiva, FOD, Universidad Autónoma de Nuevo León

Monterrey, N.L., 64460, Mexico

Location

Related Publications (3)

• Anton SD, Hida A, Heekin K, Sowalsky K, Karabetian C, Mutchie H, Leeuwenburgh C, Manini TM, Barnett TE. Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials. Nutrients. 2017 Jul 31;9(8):822. doi: 10.3390/nu9080822.

  PMID: 28758964 BACKGROUND

• Atallah R, Filion KB, Wakil SM, Genest J, Joseph L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. Long-term effects of 4 popular diets on weight loss and cardiovascular risk factors: a systematic review of randomized controlled trials. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):815-27. doi: 10.1161/CIRCOUTCOMES.113.000723. Epub 2014 Nov 11.

  PMID: 25387778 BACKGROUND

• Seid H, Rosenbaum M. Low Carbohydrate and Low-Fat Diets: What We Don't Know and Why we Should Know It. Nutrients. 2019 Nov 12;11(11):2749. doi: 10.3390/nu11112749.

  PMID: 31726791 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Model Details: This is a randomized controlled clinical study. Subjects are assigned to one of two groups: the intervention group (group A or high protein diet or HPD) and the group without high protein diet or NHPD. The assignment is done with the use of MedCalc software and the option to create random groups. Both groups are treated equally except for the procedure or diet. The blind or double-blind procedure is not used in this study. Both groups are treated during the same study period. The maximum number of patients to be evaluated per day will be three. Patients are not mixed from one group or another in each evaluation.

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 30, 2020
• Study Start: January 13, 2020
• Primary Completion: May 9, 2020
• Study Completion: July 30, 2021
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)