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

RecruitingNAAges 60 Years - 80 YearsAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค30 or โ‰ฅ70 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)
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What it tests

  • ketogenic nutritional Supplement
  • non-ketogenic, isocaloric control
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Where

1 site
Maastricht University
Maastricht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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