NCT06511206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 4, 2025

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

June 20, 2024

Last Update Submit

April 2, 2025

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Whole-body fat oxidation

    Testday 1, 2, and 3

  • Energy expenditure

    Testday 1, 2, and 3

  • Metabolites in the blood

    Testday 1, 2, and 3

  • +1 more other outcomes

Study Arms (3)

25g MCT-based nutrient mix

EXPERIMENTAL
Dietary Supplement: 25g MCT-based nutrient mix

25g MCT-based nutrient mix + cofactors

EXPERIMENTAL
Dietary Supplement: 25g MCT-based nutrient mix + cofactors

non-ketogenic control

PLACEBO COMPARATOR
Dietary Supplement: non-ketogenic control

Interventions

25g MCT-based nutrient mixDIETARY_SUPPLEMENT

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

25g MCT-based nutrient mix
25g MCT-based nutrient mix + cofactorsDIETARY_SUPPLEMENT

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

25g MCT-based nutrient mix + cofactors
non-ketogenic controlDIETARY_SUPPLEMENT

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

non-ketogenic control

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

5,11-methenyltetrahydrohomofolate

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joris Hoeks, Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 19, 2024

Study Start

August 8, 2024

Primary Completion

March 27, 2025

Study Completion

March 31, 2025

Last Updated

April 4, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)