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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949582
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Test food containing different types of dietary protein Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-Blind Crossover Randomised Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mycoprotein as in Soup
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

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


Experimental: Mycoprotein as in Mince
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

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 Measures :
  1. Blood glucose [ Time Frame: 180 minutes ]
    Fasting and Postprandial blood glucose

  2. Blood insulin [ Time Frame: 180 minutes ]
    Fasting and Postprandial blood insulin


Secondary Outcome Measures :
  1. Subjective appetite feelings [ Time Frame: 180 minutes ]

    Measured using Visual Analogue Scale from 0 to 100 milimetres, being 100 milimetres the higher score.

    Questions assessed are:

    1. "how hungry do you feel?"
    2. "how sick do you feel?"
    3. "how strong is your desire to eat?"
    4. "how much food do you think you could eat?"
    5. "how full do you feel?"
    6. "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.


  2. Ad libitum energy intake [ Time Frame: At timepoint 180 minutes ]
    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.

  3. Energy intake 72 hours post study visit [ Time Frame: For 3 days after study visit ]
    Energy intake of free-living subjects will be measured using self reported food diaries



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949582


Contacts
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Contact: Gary Frost, PhD, RD 020 7594 0959 g.frost@imperial.ac.uk
Contact: Anna Cherta Murillo, MRs 07803076929 ac6717@ic.ac.uk

Locations
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United Kingdom
NIHR Imperial Clinical Research Facility Recruiting
London, United Kingdom, W12 0HS
Contact: Karen Mosley, PhD    020 3313 8073    K.mosley@nhs.net   
Contact: Susanne Fagerbrink    020 3313 8077    Susanne.Fagerbrink@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Gary Frost Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03949582    
Other Study ID Numbers: 18HH4870
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 2 Diabetes
South Asian
Guar gum
Mycoprotein
Caucasian
Glycaemic control
Appetite
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases