Ketone Supplements and Substrate Oxidation and Physical Performance

NCT04737694 | Unknown

• 1 other identifier: 20-07HC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized crossover study is to examine the influence of consuming a ketone ester plus carbohydrate (KE+CHO) supplement on substrate oxidation and physical performance in 15 healthy adults. Following a 48-hr muscle glycogen normalization period, volunteers will consume either an isocaloric KE+CHO (KE: 573 mg KE/kg body mass, CHO: 110 g) or isocaloric CHO drink and complete 90-min of metabolically-matched, load carriage (\~30% body mass) steady-state aerobic (\~60 ± 5 % of VO2peak) exercise on a treadmill. Glucose tracers will be used to assess glucose turnover, and contribution to exogenous and plasma glucose oxidation. Serial blood draws will be collected during each trial to assess endocrine and circulating substrate responses. After steady-state exercise volunteers will complete a time to exhaustion (TTE) physical performance tests at 85% VO2peak on a treadmill. Volunteers will then be provided with food for the remainder of the day. Following a 10-hr overnight fast, volunteers will return to the laboratory and consume the same supplement (KE+CHO or CHO) as they did the previous day. Volunteers will then perform a 4-mile load carriage time trial on a treadmill. Following a minimum 7-day washout period, volunteers will return to the laboratory to complete the second arm of the study. The primary risks associated with this study include those associated with exercise, blood draws, and gastrointestinal discomfort from the KE+CHO supplement.

Conditions

Ketosis; Glucose Metabolism

Outcome Measures

Primary Outcomes (3)

• Time to exhaustion

  Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by time to exhaustion at 85% VO2max on a treadmill compared to CHO alone

  30 minutes

• Time trial

  Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by a self paced 4 mile time trial on a treadmill compared to CHO alone

  120 minutes

• Substrate oxidatoin

  Determine the effect of KE + CHO supplementation on changes in substrate oxidation during moderate-intensity load carriage exercise compared to CHO alone.

  90 minutes

Study Arms (2)

Ketone + Carbohydrate

EXPERIMENTAL

573 mg/ kg body weight ketone ester + 110 g glucose

Dietary Supplement: Ketone ester

Carbohydrate

ACTIVE COMPARATOR

Isocaloric amount of glucose to match ketone + carbohydrate

Dietary Supplement: Glucose

Interventions

Ketone ester DIETARY_SUPPLEMENT

Oral ketone ester + glucose supplement

Ketone + Carbohydrate

Glucose DIETARY_SUPPLEMENT

Glucose supplement

Carbohydrate

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 - 39 years
• Body mass index (BMI) \< 30 kg/m2
• Routinely participate in aerobic and/or resistance exercise at least 2 days per week
• Refrain from the use of caffeine, alcohol, dietary supplements, and nicotine while consuming study diets
• Supervisor approval to participate for active duty military and federal civilian employees working within the US Army Natick Soldier Systems Center

You may not qualify if:

• Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
• Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
• Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy) to be utilized in the study or vegetarian practices
• Present condition of alcoholism, anabolic steroids, or other substance abuse issues
• Musculoskeletal injuries that compromise the ability to exercise
• Not willing to avoid non-study exercise and foods during each of the 3 day testing periods
• Blood donation within 8 weeks of beginning the study
• Pregnant or breast feeding

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

Related Publications (1)

• Howard EE, Allen JT, Coleman JL, Small SD, Karl JP, O'Fallon KS, Margolis LM. Ketone Monoester Plus Carbohydrate Supplementation Does Not Alter Exogenous and Plasma Glucose Oxidation or Metabolic Clearance Rate During Exercise in Men Compared with Carbohydrate Alone. J Nutr. 2023 Jun;153(6):1696-1709. doi: 10.1016/j.tjnut.2023.03.002. Epub 2023 Mar 8.

  PMID: 36893935 DERIVED

MeSH Terms

Conditions

Ketosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester; Glucose

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Lee M Margolis, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double blinded randomized crossover design

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: February 4, 2021
• Study Start: November 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)