Effects Of Ingesting An Energy Bar On Performance And Recovery

Healthy Clinical Trial

— NB18  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704337
• Other study ID #: IRB2017-0602F
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2018
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Commercially Available Food Bar
Active
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab - Human Clinical Research Facility	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Subjective rating of hypoglycemia	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).	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.
Secondary	Subjective rating of dizziness	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).	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.
Secondary	Subjective rating of headaches	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).	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.
Secondary	Subjective rating of fatigue	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).	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.
Secondary	Subjective rating of stomach upset	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).	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.
Secondary	Subjective rating of readiness to perform	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).	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.
Secondary	Subjective rating of pain	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).	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.
Secondary	Agility Performance Time	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).	Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment.
Secondary	Sprint Performance Times	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).	Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg extension torque	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg extension force	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg extension power	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg extension work	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg flexion torque	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg flexion force	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg flexion power	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Maximal voluntary muscle contraction (MVC) leg flexion work	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).	Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.
Secondary	Markers of Catabolism: Blood Urea Nitrogen	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).	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.
Secondary	Markers of Catabolism: Creatinine	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).	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.
Secondary	Markers of Catabolism: Lactate Dehydrogenase	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).	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.
Secondary	Markers of Catabolism: Creatine Kinase	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).	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.
Secondary	Markers of Catabolism: BUN/Creatinine Ratio	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).	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.
Secondary	Stress and Sex Hormones: Cortisol	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).	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.
Secondary	Stress and Sex Hormones: Testosterone	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).	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.
Secondary	Stress and Sex Hormones: Cortisol to Testosterone Ratio	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).	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.
Secondary	Markers of Inflammation: Interferon Gama (IFNy)	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).	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.
Secondary	Markers of Inflammation: Interleukin-13 (IL-13)	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).	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.
Secondary	Markers of Inflammation: Interleukin-1 beta (IL-1ß)	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).	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.
Secondary	Markers of Inflammation: Interleukin-4 beta (IL-4)	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).	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.
Secondary	Markers of Inflammation: Interleukin-6 beta (IL-6)	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).	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.
Secondary	Markers of Inflammation: Interleukin-8 beta (IL-8)	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).	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.
Secondary	Markers of Inflammation: Tumor Necrosis Factor alpha (TNFa)	Changes in serum blood TNFa (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).	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.