Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
Healthy Volunteers
NCT07395973

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

Led by Maastricht University Medical Center · Updated on 2026-02-09

14

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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 60 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Maastricht University

Maastricht, Netherlands

Actively Recruiting

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Research Team

M

Merel Timmermans, MSc

CONTACT

J

Joris Hoeks, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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