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

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.

Study Overview

• Status: Completed
• Conditions: Post-prandial Glycemia
• Intervention / Treatment: Dietary supplement: Water; Dietary supplement: Mulberry leaf extract

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestlé Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Water administrated just before a meal	Dietary supplement: Water; Oral administration
Experimental: Mulberry leaf extract before; 250 mg of Mulberry leaf extract was administered before a standard meal	Dietary supplement: Mulberry leaf extract; Oral administration
Experimental: Mulberry leaf extract during; 250 mg of Mulberry leaf extract was administered during a standard meal	Dietary supplement: Mulberry leaf extract; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial glucose	Incremental area under the curve	Hour 0 to hour 3 after standard meal consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C max glucose	Incremental C max	Hour 0 to hour 3 after standard meal consumption
T max glucose	Incremental T max	Hour 0 to hour 3 after standard meal consumption

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19.09 NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No