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

NCT ID: NCT05112133

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2020-02-07

Brief Summary

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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

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Conditions

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Post-prandial Glycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Water administrated just before a meal

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Mulberry leaf extract before

250 mg of Mulberry leaf extract was administered before a standard meal

Group Type EXPERIMENTAL

Mulberry leaf extract

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Mulberry leaf extract during

250 mg of Mulberry leaf extract was administered during a standard meal

Group Type EXPERIMENTAL

Mulberry leaf extract

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Interventions

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Mulberry leaf extract

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Water

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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19.09 NRC

Identifier Type: -

Identifier Source: org_study_id

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