Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects

March 4, 2024 updated by: Mars Wrigley

Determination of Glycemic Index of Cacao Fruit Pulp

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Onterio
      • Toronto, Onterio, Canada, M5C 2N8
        • INQUIS Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dextrose
Dextrose matched for available carbohydrate
Other: Dextrose
Dextrose beverage
Experimental: Cacao fruit pulp
Cacao fruit pulp matched for available carbohydrate
Other: Cacao fruit pulp
Cacao pulp puree

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose
Time Frame: 1-120 minutes
Mean plasma glucose
1-120 minutes
Incremental area under the curve
Time Frame: 1-120 minutes
Calculated from mean plasma glucose
1-120 minutes
Peak plasma glucose
Time Frame: 1-120 minutes
Peak plasma glucose (Cmax)
1-120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mars Wrigley

Collaborators

INQUIS Clinical Research

Investigators

  • Principal Investigator: Thomas Wolever, MD, PhD, INQUIS Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M.WRI-2023-INQ-2224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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