Glycemic Response of a Commercial Food Bar (NB16)

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.

Study Overview

• Status: Completed
• Conditions: Glucose and Insulin Response
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Commercially Available Food Bar

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 25 g. Dextrose	Dietary supplement: Placebo; Other Names: Dextrose Placebo
Experimental: Commercially Available Food Bar; 62 g. Fitjoy Bar	Dietary supplement: Commercially Available Food Bar; Other Names: Fitjoy Bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How a commercially available food bar affects blood glucose levels	Measured in mmol/L	One day
How a commercially available food bar affects blood insulin levels.	Measured in U/mL	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does a commercially available food bar cause hypoglycemia	Subjective questionnaire	One day
Does a commercially available food bar cause dizziness	Subjective questionnaire	One day
Does a commercially available food bar cause headaches	Subjective questionnaire	One day
Does a commercially available food bar cause fatigue	Subjective questionnaire	One day
Does a commercially available food bar cause stomach upset	Subjective questionnaire	One day

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrabolt
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB2016-0830D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No