The Impact of Ketone Monoester Intake on Post-exercise Hormonal Responses After Resistance Exercise in Young Males

NCT06683547 | Completed

• 1 other identifier: A00-M69-24B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates how orally ingested exogenous ketone monoester supplements affect circulating hormone concentrations in healthy young adult males after a single session of resistance exercise. Resistance exercise is known to stimulate an acute increase in the circulating concentration of various hormones that are involved in the regulation of muscle mass, including testosterone, growth hormone (GH), and insulin-like growth factor-1 (IGF-1). Recently, there has been growing interest in how nutritional supplements impact these natural hormone responses at rest. One such intervention is the oral ingestion of exogenous ketone body supplements. Ketone bodies (i.e., β-hydroxybutyrate (β-HB), acetoacetate (AcAc), and acetone) are naturally occurring compounds that are normally produced by the body during prolonged fasting/starvation, or in response to a "ketogenic" diet (a diet very high in fat and very low in carbohydrates). These ketone body supplements taken in the form of a ketone monoester can quickly raise blood ketone levels without needing to change your diet. Recent research has shown that the ingestion of exogenous ketone supplements or following a 'ketogenic diet' can alter the concentration of certain hormones measured in blood samples at rest. However, the effects of ketone monoester intake on the exercise-induced elevation in circulating hormones is yet to be explored. Therefore, the purpose of this study is to examine how elevated β-HB, induced via the ingestion of the ketone monoester (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate, affects blood concentrations of various anabolic hormones, during post-exercise recovery in healthy young adult males, compared to a placebo drink (flavoured water).

Conditions

Ketosis; Blood Hormones; Testing Effect of Intervention; Resistance Exercise; Ketone Body

Keywords

Ketone bodies; Exogenous ketone supplements; Resistance exercise; Testosterone; Anabolic hormones; Ketone monoester

Outcome Measures

Primary Outcomes (2)

• Area under the curve for testosterone concentration.

  Serum concentration of testosterone (nmol/l) and corresponding area under the curve (AUC), measured at baseline and over 4 hours into the post-exercise recovery period.

  Baseline and over 4 hours into the post-exercise recovery period

• Time-course data for testosterone concentration.

  Serum concentration of testosterone (nmol/l) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

  Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

Secondary Outcomes (24)

• Area under the curve for growth hormone concentration

  Baseline and over 4 hours into the post-exercise recovery period

• Time-course data for growth hormone concentration.

  Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

• Area under the curve for insulin-like growth factor-1 (IGF-1) concentration

  Baseline and 4 hours into the post-exercise recovery period

• Time-course data for IGF-1 concentration

  Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

• Area under the curve for cortisol concentration.

  Baseline and over 4 hours into the post-exercise recovery period.

Study Arms (2)

Ketone Monoester (KET)

ACTIVE COMPARATOR

Ketone monoester supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate dosed based on participants' body weight (0.36g/kg body weight). The nutritional beverage will be consumed twice: 30 minutes prior to the exercise workout (t = -60 min) and immediately following the completion of the exercise protocol (t = 0 min).

Dietary Supplement: Ketone Monoester (KET); Other: Resistance Exercise

Placebo drink

PLACEBO COMPARATOR

Flavoured water. Participants will consume this beverage twice: 30 minutes prior to the exercise workout (t = -60 min) and immediately following the completion of the exercise protocol (t = 0 min).

Dietary Supplement: Flavour matched placebo drink (CON); Other: Resistance Exercise

Interventions

Ketone Monoester (KET) DIETARY_SUPPLEMENT

Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight). The ketone brand name: delta G Oxford Ketone Ester.

Ketone Monoester (KET)

Flavour matched placebo drink (CON) DIETARY_SUPPLEMENT

\- Flavoured water (non-caloric bitter + citrus flavours)

Placebo drink

Resistance Exercise OTHER

\- 5 sets of 10 repetitions of leg press and 3 sets of 12 repetitions of leg extension/leg curl 'supersets' (1 set of each back to back with no rest in between sets) at 95% of their 10-RM. Between-set rest intervals for the leg exercises will be 60 seconds.

Ketone Monoester (KET); Placebo drink

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Cis males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male participants who are 18-40 years of age (inclusive).
• BMI \>18.5 and \<30.0 kg/m2
• Recreationally active (at least of 150 minutes of activity/week).

You may not qualify if:

• Be willing to entirely avoid alcohol consumption 48 hours prior to the test days.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
• Individuals with metabolic disorders including: Type I or Type II diabetes.
• Individuals with a history of thrombosis / cardiovascular disease, endocrine disorders
• Individuals with knee injuries (i.e., ACL injuries).
• Individuals with a positive medical history of unstable thyroid disease (i.e., hypothyroidism, hyperthyroidism, hyperparathyroidism, and hypoparathyroidism) and immune disorders.
• Individuals who have used tobacco products within the last 6 months.
• Chronic usage of medications known to modulate hormone levels (i.e. corticosteroids and hormone replacement therapy (HRT)) in the last 6 months.
• Current use of ketone supplements or adherence to a ketogenic diet.
• Formal or regular weightlifting activity within the last year.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University

Montreal, Quebec, H2W 1S4, Canada

Location

MeSH Terms

Conditions

Ketosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tyler Churchward-Venne, PhD

  Department of Kinesiology and Physical Education, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Investigators and Outcome Accessors will be blinded to the intervention and control drinks. The drinks will be flavor matched and provided in an opaque bottle. An individual not involved with the study data collection, analysis and interpretation will be designated as a study blinder and randomizer.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: January 6, 2025
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-01

Locations

CA (1)