Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: non-ketogenic control; Dietary Supplement: 25g MCT-based nutrient mix + cofactors; Dietary Supplement: 25g MCT-based nutrient mix

Study type: Interventional

Funder types: Other

Identifiers

NCT06511206

NL86023.068.23

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 3 patient groups, including a placebo group

25g MCT-based nutrient mix

Experimental group

Treatment:

Dietary Supplement: 25g MCT-based nutrient mix

25g MCT-based nutrient mix + cofactors

Experimental group

Treatment:

Dietary Supplement: 25g MCT-based nutrient mix + cofactors

non-ketogenic control

Placebo Comparator group

Treatment:

Dietary Supplement: non-ketogenic control