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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ageing, Mitochondrial Function, Physical Function, Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Fish oils and dairy fat
* Dietary Supplement: Fish oils and plant fat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oils and dairy fats<br> | Dietary Supplement: Fish oils and dairy fat<br>* 12-weeks, 3x per day<br>|
| Placebo Comparator: Fish oils and plant fats<br> | Dietary Supplement: Fish oils and plant fat<br>* 12-weeks, 3x per day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ageing, Mitochondrial Function, Physical Function, Cognitive Function, Dietary Fat