Mulberry extract to modulate blood glucose in healthy adults

Not Applicable

Completed

• Conditions: Carbohydrate absorption; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14597438
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26511964 protocol 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28225835 results

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-07-01
• Study Start: 2015-04-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

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

1. Previous diagnosis of impaired fasting glucose or impaired glucose tolerance
2. Type I/II diabetes mellitus
3. BMI <20 or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. IAUC for plasma insulin concentration over 120 minutes<br>2. IAUC for plasma glucose and insulin concentration over 120 minutes<br>3. Plasma glucose concentration at the nine timepoints<br>4. Plasma insulin concentration at the nine timepoints<br>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<br><br>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.