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The Effect of a daily dietary supplement mix on 24-Hour Metabolism and Muscle Health

The effects of a 4-week supplementation with a ketogenic nutrient mix on 24-hour substrate metabolism and muscle health - Ketomix and 24h metabolism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57929
Enrollment
38
Registered
2025-03-24
Start date
2025-11-25
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Aging, Muscle health, Metabolic health, Overweight/Obesity Aging, Muscle Health, Metabolic Health, Overweight/Obesity

Interventions

Participants are asked to consume a nutritional supplement mix or control product daily for 4 weeks. Participants are randomly assigned to the intervention order.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants provide signed and dated written informed consent prior to any study specific procedures Aged 60-80 yearsBody mass index (BMI) 25-35 kg/m2Sedentary 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

Exclusion criteria: Type 2 diabetesParticipants with active congestive heart failure and/or severe renal and or liver insufficiencyUncontrolled hypertensionAlcohol consumption of >3 servings per day for men and >2 servings per day for womenUnstable body weight (weight gain or loss > 5 kg in the last 3 months) or intention to lose weightParticipants who are on an intermittent fasting dietPrevious 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 resultsSignificant food allergies/intolerance (seriously hampering study meals or study product)Participants who do not want to be informed about unexpected medical findingsBlood 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 monthsTravel across > 1 time zone in the last 3 monthsHigh daily caffeine intake > 400mg caffeine daily (more than 4 cups of coffee or energy drinks)

Design outcomes

Primary

MeasureTime frame
The primary study objective is delta respiratory exchange ratio (from 23:00 till 04:00) (indirect calorimetry)

Secondary

MeasureTime frame
The secondary study objective is skeletal mitochondrial function

Countries

Netherlands

Contacts

Public ContactJ. Hoeks

Universiteit Maastricht

j.hoeks@maastrichtuniversity.nl+31 433881507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)