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Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

NCT03832933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2022-05-10

No results posted yet for this study

Summary

The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.

Conditions

  • Diabetes Type 2
  • Obesity
  • Diet Modification

Interventions

BEHAVIORAL

High Protein Diet

16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.

BEHAVIORAL

Standard Protein Diet

16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • James Hill, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-04-22
Completion
2022-04-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832933 on ClinicalTrials.gov