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

NCT ID: NCT03832933

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-04-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Protein Diet

Group Type: EXPERIMENTAL

High Protein Diet

Intervention Type: BEHAVIORAL

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

Standard Protein Diet

Group Type: ACTIVE_COMPARATOR

Standard Protein Diet

Intervention Type: BEHAVIORAL

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

Interventions

High Protein Diet

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

Intervention Type: 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%.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

James O. Hill

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

References

Clina JG, Sayer RD, Pan Z, Cohen CW, McDermott MT, Catenacci VA, Wyatt HR, Hill JO. High- and normal-protein diets improve body composition and glucose control in adults with type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2023 Aug;31(8):2021-2030. doi: 10.1002/oby.23815.

Reference Type: DERIVED

PMID: 37475689 (View on PubMed)

Other Identifiers

IRB-300002928

Identifier Type: -

Identifier Source: org_study_id