High-Protein Diets and Diabetes

NCT05615558 | Completed DMC

• 1 other identifier: 275134
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

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

  Change from Baseline insulin sensitivity after 5-week controlled diet

Secondary Outcomes (4)

• β-cell function

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

• Glucose control

  Change from Baseline glucose control after 5-week controlled diet

• Branched-chain amino acid (BCAA) metabolism

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

• Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire

  Change from Baseline treatment satisfaction after 5-week controlled diet

Study Arms (2)

Animal

EXPERIMENTAL

Arm of the study consuming a high-protein diet from animal sources.

Other: Dietary Intervention

Non-animal

EXPERIMENTAL

Arm of the study consuming a high-protein diet from non-animal sources.

Other: Dietary Intervention

Interventions

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.

Animal; Non-animal

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Exeter: lead
• Marlow Foods Ltd: collaborator

Study Sites (1)

Nutritional Physiology Research Unit

Exeter, Devon, EX12LU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: November 14, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

GB (1)