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Breakfast Consumption and Energy Balance in Active Adult Males

Sponsor
Ohio University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04862208
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
11.8
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exercising in the fasted state results in greater fat oxidation during exercise and results in decreased caloric intake in the meals after exercise. However, the studies that examine fasted vs. fed exercise utilize a carbohydrate-based breakfast, which can increase blood glucose and insulin concentrations, which is considered a negative consequence. A protein breakfast, which can increase satiety and rest of day energy intake could also increase resting energy expenditure as well as fat oxidation during exercise. However, comparisons between fasting exercise and pre-exercise breakfast macronutrient intake (i.e., carbohydrate vs. protein) have not been made. Therefore the purpose of this study is to investigate if eating breakfast and the composition of this breakfast before exercise has an effect on the food eaten throughout the rest of the day.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Maltodextrin supplement
  • Dietary Supplement: Whey supplement
  • Dietary Supplement: Water
  • Dietary Supplement: Maltodextrin supplement
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Comparison of Fasted vs. Carbohydrate and Protein Breakfast on Exercise Metabolism and Rest of the Day Energy Intake
Actual Study Start Date :
May 6, 2021
Actual Primary Completion Date :
Aug 27, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carbohydrate-based breakfast + exercise

maltodextrin

Dietary Supplement: Maltodextrin supplement
maltodextrin (25g in 12 oz water) 1 hour pre-exercise
Experimental: Protein-based breakfast + exercise

whey

Dietary Supplement: Whey supplement
whey (25g in 12 oz water) 1 hour pre-exercise
Experimental: Fasted breakfast + exercise

water

Dietary Supplement: Water
non-caloric control (12 oz flavored water) 1 hour pre-exercise
Sham Comparator: Carbohydrate-based breakfast + no exercise

maltodextrin

Dietary Supplement: Maltodextrin supplement
maltodextrin (25g in 12 oz water) with no exercise

Outcome Measures

Primary Outcome Measures

  1. Change in energy expenditure [immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise]

    Measured via indirect calorimetry

  2. Change in lunch energy intake [60 min post-exercise]

    measured via standardized lunch buffet

  3. Change in dinner energy intake [Day 1 (trial 1); between Days 6 and 8 (trial 2); between Days 11 and 15 (trial 3); and between Days 16 and 22 (trial 4)]

    weight of food returned the following day

  4. Change in appetite [immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch]

    measured via circulating hormones

  5. Change in blood glucose [immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner]

    measured via fingerstick blood assessment

  6. Change in subjective hunger [baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner]

    measured via 100mm visual analogue scale, higher scores indicate greater hunger

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 18-45 years old

  • regularly participate in exercise for at least 150 min per week

  • run at least 3 days per week for 30 minutes

  • able to complete a VO2max test

  • able to exercise for 45 min moderate intensity exercise at one time without breaks

Exclusion Criteria:

  • not participating in structured exercise of 150 min/week for the past 6 months

  • not running at least 3 days per week for 30 minutes

  • not attaining a VO2max of 50 ml/kg/min (60th percentile fitness classification according to the American College of Sports Medicine)

  • currently smoke or quit smoking less than one year ago.

  • diagnosed with or are being treated for a cardiovascular disease, high blood pressure, fibromyalgia, irritable bowel syndrome or a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.

  • food allergies or sensitivities.

  • not willing to have blood drawn on 4 occasions during each trial (16 total times)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio University Exercise Physiology Lab Athens Ohio United States 45701

Sponsors and Collaborators

  • Ohio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Hillman, Assistant Professor, Exercise Physiology, Ohio University
ClinicalTrials.gov Identifier:
NCT04862208
Other Study ID Numbers:
  • 20-F-9
First Posted:
Apr 27, 2021
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 9, 2021