Breakfast Consumption and Energy Balance in Active Adult Males

NCT04862208 | Completed

• 1 other identifier: 20-F-9
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Intake; Substrate Utilization; Hormones; Satiety

Outcome Measures

Primary Outcomes (6)

• Change in energy expenditure

  Measured via indirect calorimetry

  immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise

• Change in lunch energy intake

  measured via standardized lunch buffet

  60 min post-exercise

• Change in dinner energy intake

  weight of food returned the following day

  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)

• Change in appetite

  measured via circulating hormones

  immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch

• Change in blood glucose

  measured via fingerstick blood assessment

  immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner

• Change in subjective hunger

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

  baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner

Study Arms (4)

Carbohydrate-based breakfast + exercise

EXPERIMENTAL

maltodextrin

Dietary Supplement: Maltodextrin supplement

Protein-based breakfast + exercise

EXPERIMENTAL

whey

Dietary Supplement: Whey supplement

Fasted breakfast + exercise

EXPERIMENTAL

water

Dietary Supplement: Water

Carbohydrate-based breakfast + no exercise

SHAM COMPARATOR

maltodextrin

Dietary Supplement: Maltodextrin supplement

Interventions

Maltodextrin supplement DIETARY_SUPPLEMENT

maltodextrin (25g in 12 oz water) 1 hour pre-exercise

Carbohydrate-based breakfast + exercise

Whey supplement DIETARY_SUPPLEMENT

whey (25g in 12 oz water) 1 hour pre-exercise

Protein-based breakfast + exercise

Water DIETARY_SUPPLEMENT

non-caloric control (12 oz flavored water) 1 hour pre-exercise

Fasted breakfast + exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Exercise Physiology

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 27, 2021
• Study Start: May 6, 2021
• Primary Completion: August 27, 2021
• Study Completion: May 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)