The Effect of Fish Oils With Dairy or Plant Based Lipids on Mitochondrial and Physical, and Cognitive Function, in Elderly Humans

Not Applicable

Terminated

• Conditions: Cognitive Function; Mitochondrial Function; Ageing; Physical Function
• Interventions: Dietary Supplement: Fish oils and plant fat; Dietary Supplement: Fish oils and dairy fat

• Registration Number: NCT04194983
• Lead Sponsor: Maastricht University

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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study Start: 2019-12-11
• Study First Posted: 2019-12-11
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oils and plant fats	Fish oils and plant fat	-
Fish oils and dairy fats	Fish oils and dairy fat	-

Primary Outcome Measures

Name	Time	Method
Mitochondrial respiration	12 weeks	Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second

Secondary Outcome Measures

Name	Time	Method
Physical function	12 weeks	Short physical Performance Battery (SPPB)
Cognitive Function	12 Weeks	Cambridge Neuropsychological Test Automated Battery (CANTAB)

Trial Locations

Locations (2)

Wageningen University and Research; 🇳🇱 Wageningen, Gelderland, Netherlands

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands