Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: 25g MCT-based nutrient mix + cofactors; Dietary Supplement: 25g MCT-based nutrient mix; Dietary Supplement: non-ketogenic control

• Registration Number: NCT06511206
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Study Start: 2024-08-08
• Status Verified: 2024-10
• Primary Completion: 2025-03-27
• Study Completion: 2025-03-31
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
25g MCT-based nutrient mix + cofactors	25g MCT-based nutrient mix + cofactors	-
25g MCT-based nutrient mix	25g MCT-based nutrient mix	-
non-ketogenic control	non-ketogenic control	-

Primary Outcome Measures

Name	Time	Method
Plasma ketone levels	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).

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands