NCT05932420

Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training

Status unknown Phase 2 Last updated 6 July 2023

What this trial tests

Phase 2 trial testing Placebo in Exercise Adaptations in 30 participants. Status unknown.

Timeline

1 October 2022

Primary endpoint
1 May 2023

31 December 2023

Quick facts

Lead sponsor	KU Leuven
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	30
Start date	1 October 2022
Primary completion	1 May 2023
Estimated completion	31 December 2023
Sites	1 location across Belgium

Drugs / interventions tested

• Placebo
• Ketone ester

Conditions studied

• Exercise Adaptations — all drugs for Exercise Adaptations →

Sponsor

KU Leuven — full company profile →

Who can join

Adults 18 to 35, male only, with Exercise Adaptations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a recent study (Poffé et al., 2019), we demonstrated that increasing the concentration of ketone bodies in the blood through the ingestion of a ketone ester (KE) post-exercise and just before sleeping time during a 3-week overtraining period resulted in suppression of the physiological symptoms of overtraining. Consistent KE intake improved endurance performance, positively affected the autonomic regulation of the heart, suppressed the increase of nocturnal sympathetic activity, and increased spontaneous energy intake. In addition, KE intake had a positive effect on muscular adaptive response, as evidenced by the significantly increased muscular angiogenesis. Therefore, in this study, we aim to investigate whether the oral administration of ketones after exercise and just before bedtime also has a positive effect on the adaptive response during a well-dosed endurance training program. Since suppression of nocturnal sympathetic activity can positively influence sleep quality, we will also study the effect of KE and the training period on sleep quality.

To investigate this, we will use a randomized, placebo-controlled parallel research design. Well-trained male cyclists will participate in a fully controlled intervention period of 8 weeks. During the intervention period, participants will follow a supervised cycling training program (5-7 training sessions per week) with a gradual buildup aimed at improving endurance capacity.

Throughout the intervention period, participants will ingest 25g ketone ester or a corresponding placebo after each training session and 30 minutes before bedtime. Endurance performance will be evaluated before the start of the training period (pretest), after week 3 (midtest), after week 7 (posttest) of the training period, and at the end of the training intervention (posttest+taper). Additionally, blood samples will be taken at the pre-test and post-test to analyze markers of hormonal status and inflammation. Muscle biopsies will be taken from the vastus lateralis muscle of the right leg at pretest and posttest to analyze cross-sectional area, muscle fiber typing, angiogenesis, protein synthesis and degradation, mitochondrial function, and energy substrate concentrations. One month after the intervention period, an additional biopsy will be taken to study changes in gene expression (epigenetic modifications). Sleep will be evaluated via polysomnography (PSG) at the pretest, midtest and posttest. Finally, before and after the training period, resting and exercise echocardiography will be taken to investigate investigate structural and morphological changes of the heart.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.