Acute Mycoprotein Effect on Glycaemic Control in South Asians
NCT ID: NCT03949582
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2019-05-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Gary Frost
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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NIHR Imperial Clinical Research Facility
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18HH4870
Identifier Type: -
Identifier Source: org_study_id
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