Clinical trial NCT05615558: High-Protein Diets and Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Marlow Foods Ltd
First posted: 2022-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Change from Baseline insulin sensitivity after 5-week controlled diet
Secondary outcomes:
measure: β-cell function
timeFrame: Change from Baseline β-cell function after 5-week controlled diet
measure: Glucose control
timeFrame: Change from Baseline glucose control after 5-week controlled diet
measure: Branched-chain amino acid (BCAA) metabolism
timeFrame: Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet
measure: Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire
timeFrame: Change from Baseline treatment satisfaction after 5-week controlled diet
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Nutritional Physiology Research Unit
state: Devon
Study officials:
References: