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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • ketogenic nutritional Supplement

    Dietary supplement

    Daily ketogenic nutritional supplement for 4 weeks

  • non-ketogenic, isocaloric control

    Dietary supplement

    Daily control for 4 weeks

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Ketogenic nutritional supplementExperimental treatment 1 intervention
Group B: non-ketogenic, isocaloric controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Delta respiratory exchange ratio (from 23:00 till 04:00)

Measured with indirect calorimetry

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

Secondary outcomes

1

Skeletal mitochondrial function

Measured in muscle biopsy

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

Other outcomes

1

Protein and gene markers of skeletal muscle metabolism

Measured in muscle biopsy

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
2

Metabolic blood markers

Measured in blood samples

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
3

Interstitial ketone levels

Measured with a continuous ketone monitor

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
4

Interstitial glucose levels

Measured with a continuous glucose monitor

Time frame
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

Sponsors and contacts

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