Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Plasma ketone levels
Study Overview
Brief Summary
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 60-80 years
- •Body mass index (BMI) 25-35 kg/m2
- •Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- •Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Exclusion Criteria
- •Type 2 diabetes
- •Pre-diabetes based on one or a combination of the following criteria:
- •ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
- •HbA1c of 5.7-6.4%.
- •Participants with active congestive heart failure and/or severe renal and or liver insufficiency
- •Uncontrolled hypertension
- •Alcohol consumption of > 3 servings per day for man and > 2 servings per day for woman
- •Unstable body weight (weight gain or loss > 5 kg in the last 3 months)
- •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)
- •Participants who do not want to be informed about unexpected medical findings
- •Blood donation during or within 2 months prior to the study
Arms & Interventions
non-ketogenic control
Intervention: non-ketogenic control (Dietary Supplement)
25g MCT-based nutrient mix + cofactors
Intervention: 25g MCT-based nutrient mix + cofactors (Dietary Supplement)
25g MCT-based nutrient mix
Intervention: 25g MCT-based nutrient mix (Dietary Supplement)
Outcomes
Primary Outcomes
Plasma ketone levels
Time Frame: Testday 1, 2, and 3
The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC).
Secondary Outcomes
No secondary outcomes reported