Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal

Not Applicable

Completed

• Conditions: Post-prandial Glycemia
• Interventions: Dietary Supplement: Mulberry leaf extract; Dietary Supplement: Water

• Registration Number: NCT05112133
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-24
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male and female participants
• Healthy status (based on anamnesis)
• Age between 18 and 45 years
• BMI between 20 and 29.9 kg/m2
• Ability to understand and sign an informed consent form

Exclusion Criteria

• Pregnant or lactating women
• Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
• Known food allergy and intolerance to test product
• Medically known cutaneous hypersensitivity to adhesives and plasters
• Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.

Smokers

Volunteer who cannot be expected to comply with the protocol

Subject having a hierarchical link with the research team members.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mulberry leaf extract before	Mulberry leaf extract	250 mg of Mulberry leaf extract was administered before a standard meal
Mulberry leaf extract during	Mulberry leaf extract	250 mg of Mulberry leaf extract was administered during a standard meal
Control	Water	Water administrated just before a meal

Primary Outcome Measures

Name	Time	Method
Post-prandial glucose	Hour 0 to hour 3 after standard meal consumption	Incremental area under the curve

Secondary Outcome Measures

Name	Time	Method
C max glucose	Hour 0 to hour 3 after standard meal consumption	Incremental C max
T max glucose	Hour 0 to hour 3 after standard meal consumption	Incremental T max

Trial Locations

Locations (1)

Nestlé Clinical Research Unit; 🇨🇭 Lausanne, Vaud, Switzerland