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Completed

NCT Number: NCT03704337

Effects Of Ingesting An Energy Bar On Performance And Recovery

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

About this study

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.

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 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)

Treatment and study plan

Commercially Available Food Bar

Dietary Supplement

Active

Other names: Food Bar

Placebo

Dietary Supplement

Placebo

Other names: Dextrose Placebo

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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).

  26. 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).

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Effects Of Ingesting A Low Glycemic Whey Protein Energy Bar Prior, During And Following Resistance Exercise And Conditioning On Performance And Recovery

Acronym: NB18

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2018
Registry last updated
Oct 12, 2018

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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