The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07395973

Enrollment

Registered

2026-02-09

Start date

2025-11-25

Completion date

2027-10-31

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Brief summary

This study will investigate the effect of providing a daily ketogenic nutritional supplement in the evening for a prolonged time (4 weeks) to induce a mild ketogenic state during the night in healthy elderly (60-80 years), overweight/obese (BMI: 25-35 kg/m2) individuals with low physical activity, on 24h rhythmicity in energy metabolism as compared to a non-ketogenic, isocaloric control.

Interventions

DIETARY_SUPPLEMENTketogenic nutritional Supplement

Daily ketogenic nutritional supplement for 4 weeks

DIETARY_SUPPLEMENTnon-ketogenic, isocaloric control

Daily control for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Aged 60-80 years * Body mass index (BMI) 25-35 kg/m2 * Sedentary lifestyle (not more than 2 hours of structured physical activity per week in the past 3 months) * Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months) * Healthy (as determined by dependent physician based on medical questionnaire) * Regular sleeping habits (7-9h of daily sleep)

Exclusion criteria

* Type 2 diabetes * Participants with active congestive heart failure and/or severe renal and or liver insufficiency * Uncontrolled hypertension * Alcohol consumption of \>3 servings per day for men and \>2 servings per day for women * Unstable body weight (weight gain or loss \> 5 kg in the last 3 months) or intention to lose weight * Participants who are on an intermittent fasting diet * Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results * Significant food allergies/intolerance (seriously hampering study meals or study product) * Participants who do not want to be informed about unexpected medical findings * Blood donation during or within 2 months prior to the study * Disturbances in circadian rhythm determined with the follow criteria: * Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire) * Heavily varying sleep-wake rhythm * Night shift work during last 3 months * Travel across \> 1 time zone in the last 3 months * High daily caffeine intake \> 400mg (more than 4 cups of coffee or energy drinks)

Design outcomes

Primary

Measure	Time frame	Description
Delta respiratory exchange ratio (from 23:00 till 04:00)	Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control	Measured with indirect calorimetry

Secondary

Measure	Time frame	Description
Skeletal mitochondrial function	Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control	Measured in muscle biopsy

Countries

Netherlands

Contacts

CONTACTMerel Timmermans, MSc

merel.timmermans@maastrichtuniversity.nl0031 88 3887793

CONTACTJoris Hoeks, Dr.

PRINCIPAL_INVESTIGATORJoris Hoeks, Dr.

Maastricht University

PRINCIPAL_INVESTIGATORPeter Joris, Dr.