NCT05112133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

14 days

First QC Date

September 30, 2021

Last Update Submit

October 5, 2023

Conditions

Post-prandial Glycemia

Outcome Measures

Primary Outcomes (1)

  • Post-prandial glucose

    Incremental area under the curve

    Hour 0 to hour 3 after standard meal consumption

Secondary Outcomes (2)

  • C max glucose

    Hour 0 to hour 3 after standard meal consumption

  • T max glucose

    Hour 0 to hour 3 after standard meal consumption

Study Arms (3)

Control

PLACEBO COMPARATOR

Water administrated just before a meal

Dietary Supplement: Water

Mulberry leaf extract before

EXPERIMENTAL

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

Dietary Supplement: Mulberry leaf extract

Mulberry leaf extract during

EXPERIMENTAL

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

Dietary Supplement: Mulberry leaf extract

Interventions

Mulberry leaf extractDIETARY_SUPPLEMENT

Oral administration

Mulberry leaf extract beforeMulberry leaf extract during
WaterDIETARY_SUPPLEMENT

Oral administration

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Interventions

Morus albaWater

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

November 8, 2021

Study Start

January 24, 2020

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

CH(1)