Acute Mycoprotein Effect on Glycaemic Control in South Asians

Last updated: September 16, 2019
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT03949582
18HH4870
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with Type 2 Diabetes Mellitus without insulin treatment.

  • South Asian (Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, India, Pakistan and SriLanka) 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 andcontrolled for at least 2 months; regimes are expected to remain stable throughout theduration of the study or not being on anti-diabetic medication.

  • If on oral hypoglycaemic agent, participant should have the last dose at 8pm of theday 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 physicalexercise (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

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 nutritionalintake (i.e. Diabetes related constipation or diarrhoea secondary to neuropathy orchronic inflammatory bowel disease, gastrectomy, etc.)

  • Significant heart (New York Heart Association class IV), hepatic (transaminase levelsgreater 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 orwithin 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 withthe protocol requirements

  • Participation in other nutrition trials within 3 months of study entry or drug trialswithin 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

Study Design

Total Participants: 48
Study Start date:
May 01, 2019
Estimated Completion Date:
June 30, 2021

Study 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).

Connect with a study center

  • NIHR Imperial Clinical Research Facility

    London, W12 0HS
    United Kingdom

    Active - Recruiting

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