Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects

NCT ID: NCT06294938

Last Updated: 2024-03-06

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-05-23

Brief Summary

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Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp.

Detailed Description

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In an acute, open-labeled, randomized design, individuals without diabetes were studied over 120 minutes after consuming 25 grams of available carbohydrate portions of cacao pulp or dextrose.

Conditions

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Blood Sugar; High Blood Sugar; Low

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

acute, open-labeled, randomized design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dextrose

Dextrose matched for available carbohydrate

Group Type ACTIVE_COMPARATOR

Dextrose

Intervention Type OTHER

Dextrose beverage

Cacao fruit pulp

Cacao fruit pulp matched for available carbohydrate

Group Type EXPERIMENTAL

Cacao fruit pulp

Intervention Type OTHER

Cacao pulp puree

Interventions

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Cacao fruit pulp

Cacao pulp puree

Intervention Type OTHER

Dextrose

Dextrose beverage

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Subjects were males or non-pregnant females and in good health.

Exclusion Criteria: Subjects with a known history of AIDS, hepatitis, diabetes or a heart condition. Subjects taking medication or with any condition that might make participation dangerous to the subject, to others, or affect the results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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INQUIS Clinical Research

INDUSTRY

Sponsor Role collaborator

Mars Wrigley

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INQUIS Clinical Research

Locations

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INQUIS Clinical Research

Toronto, Onterio, Canada

Site Status

Countries

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Canada

Other Identifiers

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M.WRI-2023-INQ-2224

Identifier Type: -

Identifier Source: org_study_id

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