Clinical trial
The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
Recruiting now · Not applicable · 1 countries · Registry ID NCT07395973
Recruiting nowNot applicableInterventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age60 Years to 80 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity
Full registry criteria
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)
Treatments and study arms
ketogenic nutritional Supplement
Dietary Supplement
Daily ketogenic nutritional supplement for 4 weeks
non-ketogenic, isocaloric control
Dietary Supplement
Daily control for 4 weeks
Primary outcomes
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
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Maastricht University🇳🇱 Maastricht, Netherlands