Acute Mycoprotein Effect on Glycaemic Control in South Asians

NCT03949582 | Unknown

• 1 other identifier: 18HH4870
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Blood glucose

  Fasting and Postprandial blood glucose

  180 minutes

• Blood insulin

  Fasting and Postprandial blood insulin

  180 minutes

Secondary Outcomes (3)

• Subjective appetite feelings

  180 minutes

• Ad libitum energy intake

  At timepoint 180 minutes

• Energy intake 72 hours post study visit

  For 3 days after study visit

Study Arms (2)

Mycoprotein as in Soup

EXPERIMENTAL

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

Mycoprotein as in Mince

EXPERIMENTAL

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

Interventions

Test food containing different types of dietary protein OTHER

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

Mycoprotein as in Mince; Mycoprotein as in Soup

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % ≤ 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

NIHR Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gary Frost

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Frost, PhD, RD

CONTACT

020 7594 0959; g.frost@imperial.ac.uk

Anna Cherta Murillo, MRs

CONTACT

07803076929; ac6717@ic.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Crossover Randomised Controlled Trial

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 14, 2019
• Study Start: May 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)