Clinical trial NCT03949582: Acute Mycoprotein Effect on Glycaemic Control in South Asians
Official title: A Double-Blind Randomised Controlled Trial Investigating the Acute Effects of Mycoprotein on Glycaemic Control and Appetite in South Asian and Caucasian Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
South Asian
Guar gum
Mycoprotein
Caucasian
Glycaemic control
Appetite
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-Blind Crossover Randomised Controlled Trial
Primary purpose: BASIC_SCIENCE

Brief summary: Diet is the cornerstone treatment to manage blood sugar in people with Type 2 Diabetes (T2D). Fibres like guar gum and protein are macronutrients that have an effect in blood sugar levels. Mycoprotein is a fungi-based food high in both dietary fibre and protein shown to have a role in regulating blood sugar levels in healthy. However, little is known about the effects of mycoprotein on blood sugar levels in people with T2D. We are interested in South Asian because they have a different blood sugar response to the same food than a Caucasian.

The main aims of the study is to assess:

* The effect of mycoprotein in different formats (soup or mince) in blood sugar levels and appetite in South Asian and Caucasian with Type 2 Diabetes.
* The effect of the combination of mycoprotein with guar gum in different formats (soup or mince) in blood sugar levels and appetite in South Asian and Caucasian with T2D.

Detailed description: This is a double-blind crossover RCT. A total of 48 participants (24 Caucasian and 24 South Asian) with T2D and non insulin treated will be recruited. Participant will be randomly allocated to one of these two groups:

Group 1: Test food in form of soup and Group 2: Test food in form of mince. Once allocated in one of the groups, participant will consume in a random order 6 different test foods (soy, chicken, mycoprotein with and without guar gum) in a determined format (either as in soup or mince).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus without insulin treatment.
* South Asian (Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, India, Pakistan and Sri Lanka) or Caucasian Ancestry.
* Age 18-70
* 5.5% ≤ HbA1c ≤ 9.0%
* BMI ≤ 35.0
* If anti-diabetic regime or lipid lowering drugs are used, they have to be stable and controlled for at least 2 months; regimes are expected to remain stable throughout the duration of the study or not being on anti-diabetic medication.
* If on oral hypoglycaemic agent, participant should have the last dose at 8pm of the day before each study visit.
* Willingness to comply with the study protocol, including:
* Use of standard evening meal the day prior to the assessments
* Refrain from alcohol consumption (24 h prior the visit) and extraneous physical exercise (72 h prior to and during the assessments).
* Not changing physical activity routine or dietary habits for the duration of the study (except from the standard evening meal).

Exclusion Criteria:

* Not diagnosed with Type 2 Diabetes Mellitus
* Mixed ancestors
* Taking any of the following medications:
* Insulin
* Diabetic medication (except from Metformin or oral hypoglycaemic which are allowed).
* Orlistat
* Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. Diabetes related constipation or diarrhoea secondary to neuropathy or chronic inflammatory bowel disease, gastrectomy, etc.)
* Significant heart (New York Heart Association class IV), hepatic (transaminase levels greater than 3 times normal) or renal disease (requiring dialysis)
* Cancer
* Pancreatitis
* Major infections (requiring antibiotics) within 3 weeks before study entry
* Concomitant therapy with acarbose, meglitinides, insulin, systemic glucocorticoids or within 2 weeks prior to study entry
* History of alcohol and/or drug abuse
* Investigator's uncertainty about the willingness or ability of patient to comply with the protocol requirements
* Participation in other nutrition trials within 3 months of study entry or drug trials within 5 months of study end
* Current smokers
* Allergic to test food or traces contained in the test food, breathing mould, penicillin, egg, soy
* Asthmatics.
* Any condition involving the imbalance of hormones
* Hypothyroidism.
* Weight change of ≥ 5% in the preceding 3 months
* Shift workers
* Vegetarian
* Medical implants that require batteries such as heart pace makers

Primary outcomes:
measure: Blood glucose
timeFrame: 180 minutes
measure: Blood insulin
timeFrame: 180 minutes
Secondary outcomes:
measure: Subjective appetite feelings
timeFrame: 180 minutes
measure: Ad libitum energy intake
timeFrame: At timepoint 180 minutes
measure: Energy intake 72 hours post study visit
timeFrame: For 3 days after study visit
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NIHR Imperial Clinical Research Facility
Study officials:
affiliation: Imperial College London
name: Gary Frost
role: PRINCIPAL_INVESTIGATOR
References: