Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects

Blood Sugar; High Clinical Trial

Official title:

Determination of Glycemic Index of Cacao Fruit Pulp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294938
• Other study ID #: M.WRI-2023-INQ-2224
• Status: Completed
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: May 23, 2023

Study information

• Verified date: March 2024
• Source: Mars Wrigley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 23, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Sugar; High
• Hyperglycemia

Intervention

Other:
• Cacao fruit pulp
Cacao pulp puree
• Dextrose
Dextrose beverage

Locations

Country	Name	City	State
Canada	INQUIS Clinical Research	Toronto	Onterio

Sponsors (2)

Lead Sponsor	Collaborator
Mars Wrigley	INQUIS Clinical Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose	Mean plasma glucose	1-120 minutes
Primary	Incremental area under the curve	Calculated from mean plasma glucose	1-120 minutes
Primary	Peak plasma glucose	Peak plasma glucose (Cmax)	1-120 minutes