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High-Protein Diets and Diabetes (HPD)

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ClinicalTrials.gov Identifier: NCT05615558
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
Marlow Foods Ltd
Information provided by (Responsible Party):
University of Exeter

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Dietary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05615558


Contacts
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Contact: Gráinne Whelehan, BSc. 013922157 g.whelehan@exeter.ac.uk

Locations
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United Kingdom
Nutritional Physiology Research Unit Recruiting
Exeter, Devon, United Kingdom, EX12LU
Contact: Gráinne Whelehan, BSc.    013922157    g.whelehan@exeter.ac.uk   
Sponsors and Collaborators
University of Exeter
Marlow Foods Ltd
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT05615558    
Other Study ID Numbers: 275134
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases