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OpenTrials
Completed

NCT Number: NCT05615558

High-Protein Diets and Diabetes

High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. They also improve glucose control and so may be helpful for treatment of Type 2 Diabetes (T2D), particularly in the short-term, possibly via an improvement in insulin secretion. Indeed, HP diets may be uniquely effective at promoting insulin secretion in T2D, but further research is needed to understand why HP. Thus, there is an urgent need to determine how HP diets affect T2D pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. It is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable HP diet that can improve glucose control and T2D pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of T2D.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutritional Physiology Research Unit

Exeter, Devon, EX12LU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 40-70 y
  • Body-mass index of 27-45 kg/m2
  • Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only).
  • Males and females

Exclusion criteria

  • Habitual dietary intake of <0.6 or >1.2 g/kg/day protein (determined from dietary history interview given at screening)
  • Current use of insulin
  • HbA1c of 12% or more (≥108 mmol/mol)
  • Weight loss of more than 5 kg within the past 6 months
  • A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min,
  • Heart failure,
  • Participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.

Treatment and study plan

Dietary Intervention

Other

Controlled dietary intervention; all food is provided to participants after being allocated to animal or non-animal dietary protein, for a duration of 5 weeks.

Primary outcomes

  1. Insulin sensitivity

    Time frame: Change from Baseline insulin sensitivity after 5-week controlled diet

    Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity.

Secondary outcomes

  1. β-cell function

    Time frame: Change from Baseline β-cell function after 5-week controlled diet

    β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT

  2. Glucose control

    Time frame: Change from Baseline glucose control after 5-week controlled diet

    Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c.

  3. Branched-chain amino acid (BCAA) metabolism

    Time frame: Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet

    BCAA metabolism measured by plasma BCAA concentration.

  4. Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire

    Time frame: Change from Baseline treatment satisfaction after 5-week controlled diet

    Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ).

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Marlow Foods Ltd

Registry information

Official study title

The Impact of a High-Protein Diet From Animal vs. Non-Animal Sources on Insulin Sensitivity and β-cell Function in Type 2 Diabetes

Acronym: HPD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Jan 17, 2025

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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