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Effects Of Ingesting An Energy Bar On Performance And Recovery (NB18)

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ClinicalTrials.gov Identifier: NCT03704337
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Richard B. Kreider, Texas A&M University

Tracking Information
First Submitted Date  ICMJE July 12, 2018
First Posted Date  ICMJE October 12, 2018
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE December 13, 2017
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Glucose Homeostasis: Glucose [ Time Frame: 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. ]
    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).
  • Glucose Homeostasis: Insulin [ Time Frame: 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. ]
    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).
  • Glucose Homeostasis: Insulin to Glucose Ratio [ Time Frame: 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. ]
    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).
  • Exercise Glucose Response [ Time Frame: 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. ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Subjective rating of hypoglycemia [ Time Frame: 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. ]
    A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of hypoglycemia using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of dizziness [ Time Frame: 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. ]
    A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of dizziness using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of headaches [ Time Frame: 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. ]
    A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of headache using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of fatigue [ Time Frame: 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. ]
    A subjective Likert scale that asked participants to rank the frequency and severity of their perceptions of fatigue using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of stomach upset [ Time Frame: 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. ]
    A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of stomach upset using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of readiness to perform [ Time Frame: 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. ]
    A subjective Likert scale assessing readiness to perform on a visual analog scale (VAS) measured prior to supplementation, following exercise, and after 48 hours of recovery from exercise. The scale ranges from "1" - strongly disagree they are ready to perform to "5" - they strongly agree they are ready to perform. Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Subjective rating of pain [ Time Frame: 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. ]
    A subjective Likert scale that assessed perceptions of pain in response the application of a standard amount of pressure applied using an algometer and measured prior to supplementation, following exercise, and after 48 hours of recovery from exercise. The scale was a straight horizontal-line with no hash-markings only wording beneath the line, which read from left-to-right "no pain, dull ache, slight pain, more slight pain, painful, very painful, and unbearable pain". Participants were instructed to scribe one clear mark bisecting the line which represented their pain level the best for each of the three pressure application sites. A ruler was used to measure the participant's mark from the left-to-right in cm and was recorded in the data as such numerical value. Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Agility Performance Time [ Time Frame: Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment. ]
    Time in seconds to perform 3 sprints around 4 cones for the Nebraska Agility Drill (NAD) with 30-seconds recovery. The tests were performed after completing the resistance exercise once during each treatment. Individual and cumulative performance times were assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Sprint Performance Times [ Time Frame: Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment. ]
    Measured as the time (in seconds) it takes to sprint three 40-yard dashes with 30-seconds recovery. The tests were performed after completing the resistance exercise once during each treatment. Individual and cumulative performance times will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg extension torque [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Newton meters assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg extension force [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Newtons assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg extension power [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Watts assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg extension work [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Joules assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg flexion torque [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Newton Meters assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg flexion force [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Newtons assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg flexion power [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Watts assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Maximal voluntary muscle contraction (MVC) leg flexion work [ Time Frame: Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment. ]
    Measured using a Kin-Com isokinetic dynamometer and expressed in Joules assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Catabolism: Blood Urea Nitrogen [ Time Frame: 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. ]
    Changes in serum blood urea nitrogen in mmol/L (BUN) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Catabolism: Creatinine [ Time Frame: 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. ]
    Changes in serum blood creatinine (umol/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Catabolism: Lactate Dehydrogenase [ Time Frame: 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. ]
    Changes in serum blood LDH (IUl/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Catabolism: Creatine Kinase [ Time Frame: 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. ]
    Changes in serum blood CK (IUl/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Catabolism: BUN/Creatinine Ratio [ Time Frame: 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. ]
    Changes in serum blood BUN/creatinine ratio obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Stress and Sex Hormones: Cortisol [ Time Frame: 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. ]
    Changes in serum blood cortisol (ug/dL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Stress and Sex Hormones: Testosterone [ Time Frame: 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. ]
    Changes in serum blood testosterone (ng/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Stress and Sex Hormones: Cortisol to Testosterone Ratio [ Time Frame: 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. ]
    Changes in the ratio of cortisol to testosterone obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interferon Gama (IFNy) [ Time Frame: 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. ]
    Changes in serum blood IFNy (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interleukin-13 (IL-13) [ Time Frame: 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. ]
    Changes in serum blood IL-13 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interleukin-1 beta (IL-1ß) [ Time Frame: 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. ]
    Changes in serum blood IL-1ß (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interleukin-4 beta (IL-4) [ Time Frame: 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. ]
    Changes in serum blood IL-4 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interleukin-6 beta (IL-6) [ Time Frame: 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. ]
    Changes in serum blood IL-6 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Interleukin-8 beta (IL-8) [ Time Frame: 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. ]
    Changes in serum blood IL-8 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
  • Markers of Inflammation: Tumor Necrosis Factor alpha (TNFα) [ Time Frame: 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. ]
    Changes in serum blood TNFα (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Of Ingesting An Energy Bar On Performance And Recovery
Official Title  ICMJE Effects Of Ingesting A Low Glycemic Whey Protein Energy Bar Prior, During And Following Resistance Exercise And Conditioning On Performance And Recovery
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.
Detailed Description Fit-joy 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-oligosaccharides (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. Short and hard exercise produces muscle damage and soreness. The Fit-joy bar contains whey protein that previous research in the investigator's lab showed may be able to decrease the muscle damaging effects of exercise while also helping with muscle growth. The purpose of this study will be to determine if eating a Fit-joy bar before and in the middle of a hard weight training workout will promote positive results during the workout and 48 hours after the workout.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A randomized, cross-over administration of supplements with approximately 7-10 days between testing sessions.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Commercially Available Food Bar
    Active
    Other Name: Food Bar
  • Dietary Supplement: Placebo
    Placebo
    Other Name: Dextrose Placebo
Study Arms  ICMJE
  • Experimental: Commercially Available Food Bar
    62 g. Food Bar
    Intervention: Dietary Supplement: Commercially Available Food Bar
  • Placebo Comparator: Placebo
    25 g. Dextrose
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03704337
Other Study ID Numbers  ICMJE IRB2017-0602F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard B. Kreider, Texas A&M University
Study Sponsor  ICMJE Texas A&M University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard B Kreider, PhD Texas A&M University
PRS Account Texas A&M University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP