Impact of Different Carbohydrate Feedings on a Hydrogen Breath Curve and Self-reported Gastrointestinal Complaints

NCT06648967 | Active Not Recruiting

• 1 other identifier: STUDY00020453
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

GI distress is widely prevalent among athletes, ranging from 30 to 90% in recreationally and professionally active athletes. As the recipient of nutrients, the gastrointestinal (GI) tract plays an important role in athleticism. The following pilot project aims to better understand if a fructose load after hiking under heat stress will result in a meaningful hydrogen breath elevation as a marker for malabsorption in healthy participants, and if supplementation of a multi-ingredient fermented whey supplement will result in a different hydrogen breath response rate after a heat stress hiking test.

Conditions

Quality of Life

Keywords

participants; healthy subjects; women; men; malabsorption syndrome

Outcome Measures

Primary Outcomes (1)

• Hydrogen breath curve

  Fructose malabsorption will be determined by creating a hydrogen breath curve for each test day.

  Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).

Secondary Outcomes (1)

• Gastrointestinal symptoms

  Adjusted GSRS (for a 60 min period) will be used to obtain self-reported gastrointestinal distress at -65 min (before exercise), 0 min (directly after exercise), and at 60/120 and 180 min.

Study Arms (1)

Baseline exercise tests with carbohydrate feeding and after supplementation

EXPERIMENTAL

This arms includes the assessment for difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings during exercise test 1 and 2. In addition, this arm will assess hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.

Dietary Supplement: Supplementation with a multi-ingredient whey supplement

Interventions

Supplementation with a multi-ingredient whey supplement DIETARY_SUPPLEMENT

Malabsorption of two different fructose boluses at baseline and after 3 and 5 weeks of multi-ingredient whey supplementation.

Baseline exercise tests with carbohydrate feeding and after supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects living in the United States.
• Women/Men aged between 18-60 years (50-50%).
• BMI value between ≥18.5 and ≤ 30 kg/m2.
• No physical limitations (i.e., able to perform all activities associated with daily living in an independent manner).
• Written informed consent.
• Completed PAR-Q+ without any "yes" responses.
• If currently using chronically or intermittently, willing to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
• If currently using chronically or intermittently, willing to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.

You may not qualify if:

• Smoking.
• Clinical or self-perceived lactose intolerance.
• Clinical or self-perceived milk protein allergy.
• Diagnosed GI tract disorders or diseases.
• Musculoskeletal disorders.
• Diagnosed metabolic disorders (such as diabetes).
• Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
• Chronic use of gastric acid suppressing medication or anti-coagulants.
• Chronic use of anti-inflammatory medication.
• Unwilling to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
• Unwilling to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Health Futures Center

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1; Malabsorption Syndromes

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: October 3, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)