Glycemic Response of a Commercial Food Bar

NCT03166514 | Completed DMC

• 1 other identifier: IRB2016-0830D
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Glucose and Insulin Response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Does a commercially available food bar cause hypoglycemia

  One day

• Does a commercially available food bar cause dizziness

  One day

• Does a commercially available food bar cause headaches

  One day

• Does a commercially available food bar cause fatigue

  One day

• Does a commercially available food bar cause stomach upset

  One day

Study Arms (2)

Commercially Available Food Bar

EXPERIMENTAL

62 g. Fitjoy Bar

Dietary Supplement: Commercially Available Food Bar

Placebo

PLACEBO COMPARATOR

25 g. Dextrose

Dietary Supplement: Placebo

Interventions

Commercially Available Food Bar DIETARY_SUPPLEMENT

Also known as: Fitjoy Bar

Commercially Available Food Bar

Placebo DIETARY_SUPPLEMENT

Also known as: Dextrose Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas A&M University: lead
• Nutrabolt: collaborator

Study Officials

• Richard B Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Health & Kinesiology

Model Details: A randomized, cross-over administration of supplements with approximately 5-10 days between testing sessions.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 25, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share