NCT06294938

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

September 30, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

January 12, 2024

Last Update Submit

March 4, 2024

Conditions

Blood Sugar; HighBlood Sugar; Low

Outcome Measures

Primary Outcomes (3)

  • Plasma Glucose

    Mean plasma glucose

    1-120 minutes

  • Incremental area under the curve

    Calculated from mean plasma glucose

    1-120 minutes

  • Peak plasma glucose

    Peak plasma glucose (Cmax)

    1-120 minutes

Study Arms (2)

Dextrose

ACTIVE COMPARATOR

Dextrose matched for available carbohydrate

Other: Dextrose

Cacao fruit pulp

EXPERIMENTAL

Cacao fruit pulp matched for available carbohydrate

Other: Cacao fruit pulp

Interventions

Cacao fruit pulpOTHER

Cacao pulp puree

Cacao fruit pulp
DextroseOTHER

Dextrose beverage

Dextrose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INQUIS Clinical Research

Toronto, Onterio, M5C 2N8, Canada

Location

MeSH Terms

Conditions

HyperglycemiaHypoglycemia

Interventions

Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Thomas Wolever, MD, PhD

    INQUIS Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: acute, open-labeled, randomized design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

March 6, 2024

Study Start

September 30, 2022

Primary Completion

January 24, 2023

Study Completion

May 23, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)