Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

NCT ID: NCT06511206

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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25g MCT-based nutrient mix

Group Type EXPERIMENTAL

25g MCT-based nutrient mix

Intervention Type DIETARY_SUPPLEMENT

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

25g MCT-based nutrient mix + cofactors

Group Type EXPERIMENTAL

25g MCT-based nutrient mix + cofactors

Intervention Type DIETARY_SUPPLEMENT

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

non-ketogenic control

Group Type PLACEBO_COMPARATOR

non-ketogenic control

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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25g MCT-based nutrient mix

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

Intervention Type DIETARY_SUPPLEMENT

25g MCT-based nutrient mix + cofactors

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

Intervention Type DIETARY_SUPPLEMENT

non-ketogenic control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joris Hoeks, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL86023.068.23

Identifier Type: -

Identifier Source: org_study_id

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