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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cognitive Function; Ageing; Physical Function; Mitochondrial Function
• Intervention / Treatment: Dietary supplement: Fish oils and dairy fat; Dietary supplement: Fish oils and plant fat

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6700AA
      • Wageningen University and Research
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish oils and dairy fats	Dietary supplement: Fish oils and dairy fat; 12-weeks, 3x per day
Placebo Comparator: Fish oils and plant fats	Dietary supplement: Fish oils and plant fat; 12-weeks, 3x per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitochondrial respiration	Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Short physical Performance Battery (SPPB)	12 weeks
Cognitive Function	Cambridge Neuropsychological Test Automated Battery (CANTAB)	12 Weeks

Collaborators and Investigators

• Sponsor: Maastricht University
• Collaborators: Wageningen University and Research; Top Institute Food and Nutrition; Netherlands Organisation for Scientific Research
• Investigators: Principal Investigator: Patrick Schrauwen, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Ageing; Physical Function; Cognitive Function; Mitochondrial Function; Dietary Fat
• Other Study ID Numbers: NL68966.068.19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No