AzTrials
AzTrials

Type 2 Diabetes MellitusACMYCONCT03949582

Acute Mycoprotein Effect on Glycaemic Control in South Asians

A study testing Test food containing different types of dietary protein in people with Type 2 Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Test food containing different types of dietary protein
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Gary Frost, PhD, RD contact

020 7594 0959

g.frost@imperial.ac.uk

Anna Cherta Murillo, MRs contact

07803076929

ac6717@ic.ac.uk

United Kingdom1 site, 1 recruiting

  • NIHR Imperial Clinical Research Facility

    London, W12 0HS

    Karen Mosley, PhD, 020 3313 8073, K.mosley@nhs.net

    Susanne Fagerbrink, 020 3313 8077, Susanne.Fagerbrink@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

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

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.
Read the 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).

Being tested
Test food containing different types of dietary protein
Keywords
Type 2 Diabetes, South Asian, Guar gum, Mycoprotein, Caucasian, Glycaemic control, Appetite
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test food containing different types of dietary proteinOther

    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

Study groups in NCT03949582
Study groupRoleWhat they receive
Mycoprotein as in SoupExperimental24 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.
Receives: Other: Test food containing different types of dietary protein
Mycoprotein as in MinceExperimental24 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.
Receives: Other: Test food containing different types of dietary protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose

    Fasting and Postprandial blood glucose

    Measured: 180 minutes

  2. Blood insulin

    Fasting and Postprandial blood insulin

    Measured: 180 minutes

Secondary outcomes (3)

  1. Subjective appetite feelings

    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.

    Measured: 180 minutes

  2. 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.

    Measured: At timepoint 180 minutes

  3. Energy intake 72 hours post study visit

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

    Measured: For 3 days after study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start1 May 2019
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Double-Blind Crossover Randomised Controlled Trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949582
Sponsor's protocol ID
18HH4870
Acronym
ACMYCO
Status last verified
Sep 2019
First submitted
8 May 2019
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cherta-Murillo A, Zhou K, Tashkova M, Frampton J, Cepas de Oliveira AC, Ho C, Franco-Becker G, Chambers ES, Dornhorst A, Frost GS. Investigating the effects of mycoprotein and guar gum on postprandial glucose in type 2 diabetes: a double-blind randomised controlled trial. Nutr Diabetes. 2025 May 23;15(1):23. doi: 10.1038/s41387-025-00375-w.

    PubMed 40410155

Questions about this trial

What is this clinical trial studying?

A study testing Test food containing different types of dietary protein in people with Type 2 Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gary Frost, PhD, RD (020 7594 0959, g.frost@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose (time frame: 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949582, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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