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Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running

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ClinicalTrials.gov Identifier: NCT03596788
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Wilson, PhD, Old Dominion University

Brief Summary:
Several previous studies have shown that repeatedly ingesting carbohydrate supplements during exercise training sessions, over a period of days and weeks, can gradually increase carbohydrate oxidation and reduce gut discomfort during exercise. However, repeatedly ingesting large amounts of carbohydrate during training sessions can be burdensome and can cause gut distress. Thus, it would be advantageous if the same long-term benefits could be realized from consuming these carbohydrate supplements at rest instead of specifically during training sessions. Therefore, the goal of this study is to examine whether repeatedly ingesting a carbohydrate-rich beverage at rest over a 5-day period alters metabolism and gut symptoms while ingesting carbohydrate during exercise.

Condition or disease Intervention/treatment Phase
Anomalies Gastrointestinal Dietary Supplement: Carbohydrate Beverage Dietary Supplement: Placebo Beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carbohydrate Beverage
A glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days
Dietary Supplement: Carbohydrate Beverage
The carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose)

Placebo Comparator: Placebo Beverage
An artificially-sweetened beverage containing aspartame
Dietary Supplement: Placebo Beverage
The placebo beverage will contain aspartame.




Primary Outcome Measures :
  1. Change in Gastrointestinal Symptom Ratings [ Time Frame: Symptoms will be collected during a 60 minute run on a treadmill at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days. ]
    Symptoms such as nausea, fullness, belching, reflux, abdominal cramps, flatulence, and urge to defecate will be recorded on a 0-10 scale (0 = no discomfort, 10 = unbearable discomfort).

  2. Change in Hydrogen Breath Production [ Time Frame: Samples will be collected before after a 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days. ]
    Samples of expired air will be tested for hydrogen levels, a marker of carbohydrate malabsorption


Secondary Outcome Measures :
  1. Change in Carbohydrate Oxidation [ Time Frame: Respiratory gases will be collected during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days. ]
    Respiratory gases will be used to estimate carbohydrate oxidation rates.

  2. Change in Feeling Scale [ Time Frame: Ratings will be collected collected before and during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days. ]
    A bipolar scale ranging from -5 (very bad) to +5 (very good)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be currently running ≥15 miles per week
  • Have completed at least one run >60 minutes over the past month
  • Have completed one or more marathons within the past year

Exclusion Criteria:

  • Overt cardiovascular disease or metabolic disorder
  • Adverse symptoms (e.g., unusual shortness of breath, dizziness, chest pain) with exercise
  • Allergies/intolerances to any of the ingredients in the beverages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596788


Contacts
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Contact: Patrick Wilson 757-683-4783 pbwilson@odu.edu

Locations
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United States, Virginia
Human Performance Lab Recruiting
Norfolk, Virginia, United States, 23529
Contact: Patrick Wilson         
Sponsors and Collaborators
Old Dominion University
Investigators
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Principal Investigator: Patrick Wilson, PhD Old Dominion University

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Responsible Party: Patrick Wilson, PhD, Assistant Professor, Old Dominion University
ClinicalTrials.gov Identifier: NCT03596788     History of Changes
Other Study ID Numbers: 1223706-2
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities