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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: 25g MCT-based nutrient mix; Dietary supplement: 25g MCT-based nutrient mix + cofactors; Dietary supplement: non-ketogenic control

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 25g MCT-based nutrient mix	Dietary supplement: 25g MCT-based nutrient mix; The 25g MCT-based nutrient mix will be consumed two hours after breakfast.
Experimental: 25g MCT-based nutrient mix + cofactors	Dietary supplement: 25g MCT-based nutrient mix + cofactors; The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast.
Placebo Comparator: non-ketogenic control	Dietary supplement: non-ketogenic control; The non-ketogenic control will be consumed two hours after breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma ketone levels	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).	Testday 1, 2, and 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-body fat oxidation	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.	Testday 1, 2, and 3
Energy expenditure	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.	Testday 1, 2, and 3
Metabolites in the blood	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.	Testday 1, 2, and 3
Interstitial ketone levels	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.	Testday 1, 2, and 3

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Joris Hoeks, Dr., Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: NL86023.068.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No