NCT03596788

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6.6 years

First QC Date

June 28, 2018

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Gastrointestinal Symptom Ratings

    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).

    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.

  • Change in Hydrogen Breath Production

    Samples of expired air will be tested for hydrogen levels, a marker of carbohydrate malabsorption

    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.

Secondary Outcomes (2)

  • Change in Carbohydrate Oxidation

    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.

  • Change in Feeling Scale

    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.

Study Arms (2)

Carbohydrate Beverage

EXPERIMENTAL

A glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days

Dietary Supplement: Carbohydrate Beverage

Placebo Beverage

PLACEBO COMPARATOR

An artificially-sweetened beverage containing aspartame

Dietary Supplement: Placebo Beverage

Interventions

Carbohydrate BeverageDIETARY_SUPPLEMENT

The carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose)

Carbohydrate Beverage
Placebo BeverageDIETARY_SUPPLEMENT

The placebo beverage will contain aspartame.

Placebo Beverage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Lab

Norfolk, Virginia, 23529, United States

Location

Study Officials

  • Patrick Wilson, PhD

    Old Dominion University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 24, 2018

Study Start

August 1, 2018

Primary Completion

February 17, 2025

Study Completion

February 17, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations