NCT03704337

Brief Summary

The purpose of this study is to determine the effects of ingesting a low glycemic whey protein energy bar prior, during and following resistance exercise and conditioning on performance and recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

July 12, 2018

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Glucose Homeostasis: Glucose

    Changes in serum blood glucose (mmol/L) obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Glucose Homeostasis: Insulin

    Changes in serum insulin (µIU/mL) obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Glucose Homeostasis: Insulin to Glucose Ratio

    Changes the insulin to glucose ratio obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Exercise Glucose Response

    Changes in arterialized-venous blood glucose (mmol/L) obtained from a dry finger and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    Measured at baseline (0-min); 30-min post ingestion of supplement, midway (60-min) and following (90-min) resistance exercise, following sprint condition exercises (110-min), and following post-exercise assessments (130-min) during each treatment.

Secondary Outcomes (32)

  • Subjective rating of hypoglycemia

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Subjective rating of dizziness

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Subjective rating of headaches

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Subjective rating of fatigue

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • Subjective rating of stomach upset

    Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.

  • +27 more secondary outcomes

Study Arms (2)

Commercially Available Food Bar

EXPERIMENTAL

62 g. Food Bar

Dietary Supplement: Commercially Available Food Bar

Placebo

PLACEBO COMPARATOR

25 g. Dextrose

Dietary Supplement: Placebo

Interventions

Active

Also known as: Food Bar
Commercially Available Food Bar
PlaceboDIETARY_SUPPLEMENT

Placebo

Also known as: Dextrose Placebo
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is between the ages of 18 and 35
  • Participant is apparently healthy
  • Participant is involved in a a consistent strength and conditioning program consisting of upper and lower body resistance exercises as well as cardiovascular or sprint conditioning training (for at least the past year for 2-4 days/week), bench press at least your body weight and squat at least 1.5 times your body weight and/or leg press twice your body weight.
  • Participant has a Body Mass Index (BMI) \< 24.9 or Body Fat Percentage (%BF) \< 25.0

You may not qualify if:

  • Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia, cardiovascular disease
  • Participant has a food allergy (i.e., milk, soy, egg, wheat or nuts)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

Location

Related Publications (1)

  • Grubic TJ, Sowinski RJ, Nevares BE, Jenkins VM, Williamson SL, Reyes AG, Rasmussen C, Greenwood M, Murano PS, Earnest CP, Kreider RB. Comparison of ingesting a food bar containing whey protein and isomalto-oligosaccharides to carbohydrate on performance and recovery from an acute bout of resistance-exercise and sprint conditioning: an open label, randomized, counterbalanced, crossover pilot study. J Int Soc Sports Nutr. 2019 Aug 13;16(1):34. doi: 10.1186/s12970-019-0301-z.

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
Model Details: A randomized, cross-over administration of supplements with approximately 7-10 days between testing sessions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Human Clinical Research Facility

Study Record Dates

First Submitted

July 12, 2018

First Posted

October 12, 2018

Study Start

December 13, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations