High-Protein Diets and Diabetes (HPD)

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Dietary Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gráinne Whelehan, BSc.; Phone Number: 013922157; Email: g.whelehan@exeter.ac.uk

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX12LU
      • Recruiting
      • Nutritional Physiology Research Unit
      • Contact: Gráinne Whelehan, BSc.; Phone Number: 013922157; Email: g.whelehan@exeter.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animal; Arm of the study consuming a high-protein diet from animal sources.	Other: Dietary Intervention; 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.
Experimental: Non-animal; Arm of the study consuming a high-protein diet from non-animal sources.	Other: Dietary Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
β-cell function	β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT	Change from Baseline β-cell function after 5-week controlled diet
Glucose control	Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c.	Change from Baseline glucose control after 5-week controlled diet
Branched-chain amino acid (BCAA) metabolism	BCAA metabolism measured by plasma BCAA concentration.	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	Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ).	Change from Baseline treatment satisfaction after 5-week controlled diet

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: Marlow Foods Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 275134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No