NCT05439720

Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added. Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone ester	A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.
DIETARY_SUPPLEMENT	Placebo	Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.
BEHAVIORAL	Exercise	A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime

Timeline

• Start date: 2022-05-15
• Primary completion: 2022-07-01
• Completion: 2022-08-15
• First posted: 2022-06-30
• Last updated: 2022-06-30

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study