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Completed

NCT Number: NCT06511206

Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25g MCT-based nutrient mix

Dietary Supplement

The 25g MCT-based nutrient mix will be consumed two hours after breakfast.

25g MCT-based nutrient mix + cofactors

Dietary Supplement

The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast.

non-ketogenic control

Dietary Supplement

The non-ketogenic control will be consumed two hours after breakfast.

Primary outcomes

  1. 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).

Other outcomes

  1. Whole-body fat oxidation

    Time frame: Testday 1, 2, and 3

    An exploratory outcome is the whole-body fat oxidation / substrate utilization determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as g/min and respiratory exchange ratio.

  2. Energy expenditure

    Time frame: Testday 1, 2, and 3

    An exploratory outcome is the energy expenditure determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as kJ/min.

  3. Metabolites in the blood

    Time frame: Testday 1, 2, and 3

    An exploratory outcome is the plasma metabolite levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as i.e. glucose in mmol/L, insulin in pmol/L.

  4. Interstitial ketone levels

    Time frame: Testday 1, 2, and 3

    An exploratory outcome is the interstitial ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as μM.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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