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OpenTrials
Completed

NCT Number: NCT05112133

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.

Completed

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Key information

Conditions

Post-prandial Glycemia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mulberry Leaf Extract

Dietary Supplement

Oral administration

Water

Dietary Supplement

Oral administration

Primary outcomes

  1. Post-prandial glucose

    Time frame: Hour 0 to hour 3 after standard meal consumption

    Incremental area under the curve

Secondary outcomes

  1. C max glucose

    Time frame: Hour 0 to hour 3 after standard meal consumption

    Incremental C max

  2. T max glucose

    Time frame: Hour 0 to hour 3 after standard meal consumption

    Incremental T max

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.