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

Primary Purpose

Diabetes Type 2, Obesity, Diet Modification

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High Protein Diet

Standard Protein Diet

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring weight loss, dietary protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham
University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Protein Diet

Standard Protein Diet

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight by weight scale

Participant body weights will be measured on a kg scale

Change in body weight by weight scale

Participant body weights will be measured on a kg scale

Secondary Outcome Measures

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%.

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.

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.

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.

Change in % FFM

Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Full Information

NCT ID

NCT03832933

First Posted

February 5, 2019

Last Updated

May 7, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03832933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

April 22, 2022 (Actual)

Study Completion Date

April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 2, Obesity, Diet Modification

Keywords

weight loss, dietary protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Protein Diet

Arm Type

Experimental

Arm Title

Standard Protein Diet

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

High Protein Diet

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Standard Protein Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight by weight scale

Description

Participant body weights will be measured on a kg scale

Time Frame

Baseline to 16 weeks

Title

Change in body weight by weight scale

Description

Participant body weights will be measured on a kg scale

Time Frame

Baseline to 52 weeks

Secondary Outcome Measure Information:

Title

Change in T2D diagnosis criteria

Description

T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose <126 mg/dL or hemoglobin A1c <6.5%.

Time Frame

Baseline to 52 weeks.

Title

Change in % body fat

Description

Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Time Frame

Baseline to 16 weeks

Title

Change in % body fat

Description

Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Time Frame

Baseline to 52 weeks.

Title

Change in % fat free mass (FFM)

Description

Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Time Frame

Baseline to 16 weeks.

Title

Change in % FFM

Description

Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Time Frame

Baseline to 52 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Hill, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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