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Glucose and Insulin ResponseNB16NCT03166514

Glycemic Response of a Commercial Food Bar

A study testing Commercially Available Food Bar in people with Glucose and Insulin Response, run by Texas A&M University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine the glucose and insulin response to a food bar. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Glucose and Insulin Response
What is being tested?
Commercially Available Food Bar
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 1 May 2017
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant is between the ages of 18 and 35
  • Participant is apparently healthy
  • Participant is moderately active and participants in low intensity recreational activity at lease 3 to 4 days a week
  • Participant has a BMI < 24.9

Who cannot join

  • Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmais, cardiovascular disease
  • Participant uses current prescription medication (birth control is allowed)
  • Participant is pregnant or nursing or plans to become pregnant during the next month
  • Participant has an intolerance to caffeine and/or other natural stimulants
  • Participant has a history of smoking
  • Participant drinks excessively (i.e., 12 drinks per week or more)

About this study

Official title: Pharmacokinetic and Glycemic Response of a Commercially Available Food Bar

The purpose of this study is to examine the glucose and insulin response to a food bar.

Read the detailed description

Fitjoy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligoshaccaride (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. To date, no research has been performed on the glycemic response to ingesting IMO in combination with other constituents. Therefore the purpose of this study is to determine the glycemic index of the Fitjoy bar.

Being tested
Commercially Available Food Bar, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Commercially Available Food BarDietary supplement

    Also called Fitjoy Bar

  • PlaceboDietary supplement

    Also called Dextrose Placebo

Study groups in NCT03166514
Study groupRoleWhat they receive
Commercially Available Food BarExperimental62 g. Fitjoy Bar
Receives: Dietary Supplement: Commercially Available Food Bar
PlaceboPlacebo comparator25 g. Dextrose
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. How a commercially available food bar affects blood glucose levels

    Measured in mmol/L

    Measured: One day

  2. How a commercially available food bar affects blood insulin levels.

    Measured in U/mL

    Measured: One day

Secondary outcomes (5)

  1. Does a commercially available food bar cause hypoglycemia

    Subjective questionnaire

    Measured: One day

  2. Does a commercially available food bar cause dizziness

    Subjective questionnaire

    Measured: One day

  3. Does a commercially available food bar cause headaches

    Subjective questionnaire

    Measured: One day

  4. Does a commercially available food bar cause fatigue

    Subjective questionnaire

    Measured: One day

  5. Does a commercially available food bar cause stomach upset

    Subjective questionnaire

    Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2017
  2. Study start1 Jan 2017
  3. Primary completion1 May 2017
  4. Study completion1 May 2017

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
A randomized, cross-over administration of supplements with approximately 5-10 days between testing sessions.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166514
Sponsor's protocol ID
IRB2016-0830D
Acronym
NB16
Status last verified
Apr 2020
First submitted
5 May 2017
Last updated
13 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Commercially Available Food Bar in people with Glucose and Insulin Response, run by Texas A&M University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

How a commercially available food bar affects blood glucose levels (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03166514.

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 13 Apr 2020.

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