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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diet Modification; Diabetes Type 2
• Intervention / Treatment: Behavioral: High Protein Diet; Behavioral: Standard Protein Diet

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Age ≥18 years
• T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)
• BMI of ≥27 kg/m2
• Weight stable (±3kg in the last 3 months)
• Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage
• Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period.

Exclusion Criteria:

• HbA1c concentration of ≥12%.
• Pregnant or lactating within the past 6 months or trying to become pregnant.
• Individuals following a vegetarian/vegan only diet
• Food allergies (to red meats or other common protein sources)
• Using exogenous insulin for T2D management
• Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study.
• Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
• Current Eating disorder (anorexia or bulimia)
• Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable.
• Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Protein Diet	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%.
ACTIVE_COMPARATOR: Standard Protein Diet	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight by weight scale	Participant body weights will be measured on a kg scale	Baseline to 16 weeks
Change in body weight by weight scale	Participant body weights will be measured on a kg scale	Baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in T2D diagnosis criteria	T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose <126 mg/dL or hemoglobin A1c <6.5%.	Baseline to 52 weeks.
Change in % body fat	Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 16 weeks
Change in % body fat	Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 52 weeks.
Change in % fat free mass (FFM)	Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 16 weeks.
Change in % FFM	Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 52 weeks.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: James Hill, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): April 22, 2022
• Study Completion (ACTUAL): April 22, 2022

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: weight loss; dietary protein
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-300002928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No