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Acute Mycoprotein Effect on Glycaemic Control in South Asians (ACMYCO)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Test food containing different types of dietary protein

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes, South Asian, Guar gum, Mycoprotein, Caucasian, Glycaemic control, Appetite

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NIHR Imperial Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mycoprotein as in Soup

Mycoprotein as in Mince

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood glucose

Fasting and Postprandial blood glucose

Blood insulin

Fasting and Postprandial blood insulin

Secondary Outcome Measures

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.

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.

Energy intake 72 hours post study visit

Energy intake of free-living subjects will be measured using self reported food diaries

Full Information

NCT ID

NCT03949582

First Posted

May 8, 2019

Last Updated

September 16, 2019

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT03949582

Brief Title

Acute Mycoprotein Effect on Glycaemic Control in South Asians

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes, South Asian, Guar gum, Mycoprotein, Caucasian, Glycaemic control, Appetite

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Double-Blind Crossover Randomised Controlled Trial

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mycoprotein as in Soup

Arm Type

Experimental

Arm Description

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.

Arm Title

Mycoprotein as in Mince

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Test food containing different types of dietary protein

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood glucose

Description

Fasting and Postprandial blood glucose

Time Frame

180 minutes

Title

Blood insulin

Description

Fasting and Postprandial blood insulin

Time Frame

180 minutes

Secondary Outcome Measure Information:

Title

Subjective appetite feelings

Description

Time Frame

180 minutes

Title

Ad libitum energy intake

Description

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.

Time Frame

At timepoint 180 minutes

Title

Energy intake 72 hours post study visit

Description

Energy intake of free-living subjects will be measured using self reported food diaries

Time Frame

For 3 days after study visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Frost, PhD, RD

Phone

020 7594 0959

g.frost@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Cherta Murillo, MRs

Phone

07803076929

ac6717@ic.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Frost

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

NIHR Imperial Clinical Research Facility

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Mosley, PhD

Phone

020 3313 8073

K.mosley@nhs.net

First Name & Middle Initial & Last Name & Degree

Susanne Fagerbrink

Phone

020 3313 8077

Susanne.Fagerbrink@nhs.net

12. IPD Sharing Statement

Plan to Share IPD

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