Recruiting NCT07395973
The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ketogenic nutritional Supplement, non-ketogenic, isocaloric control.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 supplement ketogenic nutritional Supplement
Daily ketogenic nutritional supplement for 4 weeks - Dietary supplement non-ketogenic, isocaloric control
Daily control for 4 weeks
Primary outcome measures
- Delta respiratory exchange ratio (from 23:00 till 04:00) [Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control]
Secondary outcome measures (1)
- Skeletal mitochondrial function [Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- Maastricht University — Maastricht
Identifiers
NCT: NCT07395973 · NL-009725