Acute Mycoprotein Effect on Glycaemic Control in South Asians

Type 2 Diabetes Mellitus Clinical Trial

— ACMYCO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949582
• Other study ID #: 18HH4870
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2019
• Source: Imperial College London
• Contact: Gary Frost, PhD, RD
• Phone: 020 7594 0959
• Email: g.frost[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Test food containing different types of dietary protein
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

Locations

Country	Name	City	State
United Kingdom	NIHR Imperial Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	Fasting and Postprandial blood glucose	180 minutes
Primary	Blood insulin	Fasting and Postprandial blood insulin	180 minutes
Secondary	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
Secondary	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
Secondary	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