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

Nestlé

Status: Completed

Conditions: Post-prandial Glycemia

Treatments: Dietary Supplement: Water; Dietary Supplement: Mulberry leaf extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT05112133

19.09 NRC

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Water administrated just before a meal

Treatment:

Dietary Supplement: Water

Mulberry leaf extract before

Experimental group

Description:

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

Treatment:

Dietary Supplement: Mulberry leaf extract

Mulberry leaf extract during

Experimental group

Description:

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

Treatment:

Dietary Supplement: Mulberry leaf extract