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Completed

NCT Number: NCT03832933

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Protein Diet

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

Behavioral

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

Primary outcomes

  1. Change in body weight by weight scale

    Time frame: Baseline to 16 weeks

    Participant body weights will be measured on a kg scale

  2. Change in body weight by weight scale

    Time frame: Baseline to 52 weeks

    Participant body weights will be measured on a kg scale

Secondary outcomes

  1. Change in T2D diagnosis criteria

    Time frame: Baseline to 52 weeks.

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

  2. Change in % body fat

    Time frame: Baseline to 16 weeks

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

  3. Change in % body fat

    Time frame: Baseline to 52 weeks.

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

  4. Change in % fat free mass (FFM)

    Time frame: Baseline to 16 weeks.

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

  5. Change in % FFM

    Time frame: Baseline to 52 weeks.

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2019
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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