Mulberry extract to modulate blood glucose in healthy adults

Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14597438

Enrollment

Registered

2015-04-21

Start date

2014-01-01

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbohydrate absorption Nutritional, Metabolic, Endocrine

Interventions

The study will evaluate single doses (500 mg, 250 mg and 125 mg) of mulberry extract given at least 48 hours apart against placebo: 1. 500 mg mulberry extract (IminiNorm capsule) (equivalent to 25 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consent to study protocol 2. Age 18-65 years 3. BMI 20-30 4. Normal fasting glucose (fasting plasma glucose concentration <= 7.0 mmol/l)

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of impaired fasting glucose or impaired glucose tolerance 2. Type I/II diabetes mellitus 3. BMI 30 4. Alcohol consumption in the previous 12 hours 5. Current oral hypoglycaemic medication use 6. Pregnancy or breastfeeding 7. Symptomatic irritable bowel syndrome 8. Current participation in another clinical trial 9. History of renal or liver disease 10. History of clotting or bleeding disorders 11. Taken antibiotics in the last 3 weeks prior to screening 12. Taking daily medications or dietary supplements that are not suitable for the study in the opinion of the principal investigator and/or that are prohibited (as per protocol) 13. Known intolerance or allergy to mulberry extract or any ingredients in the study products

Design outcomes

Primary

Measure	Time frame
Incremental area-under-the-curve (IAUC) for plasma glucose concentration over 120 minutes. The glucose and insulin values will be measured every 15 mins for two hours eg. 0, 15, 30, 45, 60, 75, 90, 105, 120 mins at each visit.	—

Secondary

Measure	Time frame
1. IAUC for plasma insulin concentration over 120 minutes 2. IAUC for plasma glucose and insulin concentration over 120 minutes 3. Plasma glucose concentration at the nine timepoints 4. Plasma insulin concentration at the nine timepoints 5. Gastrointestinal tolerability - abdominal bloating may be experienced due to reduced carbohydrate absorption. Gastrointestinal symptoms will be measured via questionnaire for 24 hours following each study visit The glucose and insulin values will be measured every 15 mins for two hours eg. 0, 15, 30, 45, 60, 75, 90, 105, 120 mins at each visit.	—

Measure

Time frame

1. IAUC for plasma insulin concentration over 120 minutes 2. IAUC for plasma glucose and insulin concentration over 120 minutes 3. Plasma glucose concentration at the nine timepoints 4. Plasma insulin concentration at the nine timepoints 5. Gastrointestinal tolerability - abdominal bloating may be experienced due to reduced carbohydrate absorption. Gastrointestinal symptoms will be measured via questionnaire for 24 hours following each study visit The glucose and insulin values will be measured every 15 mins for two hours eg. 0, 15, 30, 45, 60, 75, 90, 105, 120 mins at each visit.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026