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NCT06511206Completed

Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

Source: ClinicalTrials.gov · Last updated 4 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
11 (actual)
First submitted
20 Jun 2024
Start date
8 Aug 2024
Primary completion date
27 Mar 2025
Lead sponsor
Maastricht University Medical Center
Diseases
Obesity
NCT number
NCT06511206

What you commit to

  • Study type: Interventional
  • Participants enrolled: 11
  • From 8 Aug 2024 to the primary completion date, 27 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Blood donation during or within 2 months prior to the study

Other illness

  • Type 2 diabetes
  • Participants with active congestive heart failure and/or severe renal and or liver insufficiency
  • Uncontrolled hypertension
  • Significant food allergies/intolerance (seriously hampering study meals)

Lab values

  • 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%.

Other

  • 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)
  • Participants who do not want to be informed about unexpected medical findings

Who the study is looking for

  • 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

Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Maastricht University
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.