Acute Mycoprotein Effect on Glycaemic Control in South Asians

Study Overview
=================
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).

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Test food containing different types of dietary protein


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-Blind Crossover Randomised Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycoprotein as in Soup<br>24 will be randomised to soup (12 caucasian and 12 south asian) in order to test raw mycoprotein. Test food will be administrated orally and allowed 15 minutes for consumption at an even pace. | Other: Test food containing different types of dietary protein<br>* The test foods will be (in six study visits): Soy mince/soup Chicken mince/soup Quorn mince/soup Soy mince/soup with guar gum Chicken mince/soup with guar gum Quorn mince/soup with guar gum<br>|
| Experimental: Mycoprotein as in Mince<br>24 will be randomised to mince (12 caucasian and 12 south asian) in order to test processed mycoprotein (Quorn). Test food will be administrated orally and allowed 15 minutes for consumption at an even pace. | Other: Test food containing different types of dietary protein<br>* The test foods will be (in six study visits): Soy mince/soup Chicken mince/soup Quorn mince/soup Soy mince/soup with guar gum Chicken mince/soup with guar gum Quorn mince/soup with guar gum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Fasting and Postprandial blood glucose | 180 minutes | 
| Blood insulin | Fasting and Postprandial blood insulin | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite feelings | Measured using Visual Analogue Scale from 0 to 100 milimetres, being 100 milimetres the higher score. Questions assessed are: how hungry do you feel? how sick do you feel? how strong is your desire to eat? how much food do you think you could eat? how full do you feel? what is your level of satiety? For questions 1 to 4 the desirable outcome considered as good result for the test food mycoprotein are values less than 30 milimetres, and for questions 5 and 6, values above 60 milimetres. | 180 minutes | 
| Ad libitum energy intake | Measured using a buffet meal composed of wihte pasta with tomato sauce and weighting the serving bowl before and after to measure consumed grams of food. | At timepoint 180 minutes | 
| Energy intake 72 hours post study visit | Energy intake of free-living subjects will be measured using self reported food diaries | For 3 days after study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, South Asian, Guar gum, Mycoprotein, Caucasian, Glycaemic control, Appetite