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OpenTrials
Completed

NCT Number: NCT03166514

Glycemic Response of a Commercial Food Bar

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Commercially Available Food Bar

Dietary Supplement

Other names: Fitjoy Bar

Placebo

Dietary Supplement

Other names: Dextrose Placebo

Primary outcomes

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

    Time frame: One day

    Measured in mmol/L

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

    Time frame: One day

    Measured in U/mL

Secondary outcomes

  1. Does a commercially available food bar cause hypoglycemia

    Time frame: One day

    Subjective questionnaire

  2. Does a commercially available food bar cause dizziness

    Time frame: One day

    Subjective questionnaire

  3. Does a commercially available food bar cause headaches

    Time frame: One day

    Subjective questionnaire

  4. Does a commercially available food bar cause fatigue

    Time frame: One day

    Subjective questionnaire

  5. Does a commercially available food bar cause stomach upset

    Time frame: One day

    Subjective questionnaire

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Nutrabolt

Registry information

Official study title

Pharmacokinetic and Glycemic Response of a Commercially Available Food Bar

Acronym: NB16

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 25, 2017
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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