Blood Sugar; HighNCT06294938
Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects
A study testing Cacao fruit pulp and Dextrose in people with Blood Sugar; High and Blood Sugar; Low, run by Mars Wrigley at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar; High, Blood Sugar; Low
- What is being tested?
- Cacao fruit pulp and Dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2022to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Sugar; High, Blood Sugar; Low
- Being tested
- Cacao fruit pulp, Dextrose
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cacao fruit pulpOther
Cacao pulp puree
DextroseOther
Dextrose beverage
| Study group | Role | What they receive |
|---|---|---|
| Dextrose | Active comparator | Dextrose matched for available carbohydrate Receives: Other: Dextrose |
| Cacao fruit pulp | Experimental | Cacao fruit pulp matched for available carbohydrate Receives: Other: Cacao fruit pulp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose
Mean plasma glucose
Measured: 1-120 minutes
Incremental area under the curve
Calculated from mean plasma glucose
Measured: 1-120 minutes
Peak plasma glucose
Peak plasma glucose (Cmax)
Measured: 1-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start30 Sep 2022
- Primary completion24 Jan 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sugar; HighStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- acute, open-labeled, randomized design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mars Wrigley
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, MD, PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294938
- Sponsor's protocol ID
- M.WRI-2023-INQ-2224
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Glycemic Index of Cacao Fruit Pulp
- ClinicalTrials.gov ID
- NCT06294938
- Acronym / sponsor ID
- M.WRI-2023-INQ-2224
- Conditions
- Blood Sugar; High, Blood Sugar; Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mars WrigleyIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- acute, open-labeled, randomized design
| Arm | Type | Receives |
|---|---|---|
| Dextrose | Active comparator | Other: DextroseDextrose matched for available carbohydrate |
| Cacao fruit pulp | Experimental | Other: Cacao fruit pulpCacao fruit pulp matched for available carbohydrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cacao fruit pulpCacao pulp puree | Other | Cacao fruit pulp |
| DextroseDextrose beverage | Other | Dextrose |
Primary outcome
Plasma Glucose
Time frame: 1-120 minutes
Mean plasma glucose
Incremental area under the curve
Time frame: 1-120 minutes
Calculated from mean plasma glucose
Peak plasma glucose
Time frame: 1-120 minutes
Peak plasma glucose (Cmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wolever, MD, PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cacao fruit pulp and Dextrose in people with Blood Sugar; High and Blood Sugar; Low, run by Mars Wrigley at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Glucose (time frame: 1-120 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.