Clinical trial NCT04194983: The Effect of Fish Oils With Dairy or Plant Based Lipids on Mitochondrial and Physical, and Cognitive Function, in Elderly Humans
Official title: To Examine the Effect of Dietary Supplementation With Fish Oils With Dairy or Plant Based Lipids on Mitochondrial, Physical, and Cognitive Function, in Elderly Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ageing
Mitochondrial Function
Physical Function
Cognitive Function
Keywords: Ageing
Mitochondrial Function
Physical Function
Cognitive Function
Dietary Fat
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
name: Netherlands Organisation for Scientific Research
name: Top Institute Food and Nutrition
First posted: 2019-12-11
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, double-blind, randomised, controlled, parallel trial, where fish oils combined with dairy or plant based fat supplements are consumed for 12-weeks.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial, physical, and cognitive function.

Detailed description: Physical and cognitive function decline as we get older and this may be due to changes within the mitochondria, organelles that regulate energy production in our cells. The ability of the mitochondria to produce energy can be affected by diet, and the composition of lipids in the cell is an important factor in determining how effective our mitochondria are. Dairy and plant based lipids differ in composition and therefore may differ in their ability to affect mitochondrial function when combined with fish oils (FO). The primary objective of this study is to determine whether supplementation with dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial function. Additional exploratory objectives are 1) skeletal muscle and physical function and 2) cognitive function.

Eligibility criteria: Inclusion Criteria:

* Male or/and female;
* Caucasian;
* Age ≥ 65 years;
* BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
* Normal physical activity levels: maximum of 1 hour per week engagement in structured exercise of moderate to high intensity;
* Subject should be in sufficient health to participate in the experiments, to be judged by the site-specific responsible physician, based on the subject's medical history.

Exclusion Criteria:

* Habitual smoker within the past 5 years;
* Excessive alcohol use (greater than 20g per day) and/or drug abuse;
* Subjects with diagnosed diabetes mellitus type 2;
* Significant food allergies or intolerances concerning the study products, e.g. cow's milk protein allergy
* Participation in another biomedical study possibly interfering with the study results within 1 month before the first study visit;
* Medication use e.g. antithrombotic medications known to hamper subject's safety during the study procedures;
* Subjects habitually taking fish oil supplements within 3-months of the initial study visit or habitually taking supplements that are likely to affect the main study outcomes;
* Subjects who do not want to be informed about unexpected medical findings;
* Subjects who do not want their treating physician to be informed about unexpected medical findings;
* Inability to participate and/or complete the required measurements

Primary outcomes:
measure: Mitochondrial respiration
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical function
timeFrame: 12 weeks
measure: Cognitive Function
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Patrick Schrauwen, PhD
role: PRINCIPAL_INVESTIGATOR
References: