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

NCT ID: NCT04194983

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2020-10-15

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.

Conditions

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Ageing Mitochondrial Function Physical Function Cognitive Function

Keywords

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Ageing Mitochondrial Function Physical Function Cognitive Function Dietary Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
After subjects have successfully completed the screening, they will be randomly allocated in a 1:1 ratio, using a 4-code system, to one of the two interventions (intervention or control). The intervention and control will each be individually coded with a randomly generated 3 letter coding system with 2 codes allocated to intervention product and the other 2 codes allocated to the control product. sachets will be generated by the product manufacturer and the corresponding blinding label will be added to the sachets, prior to shipment to the study sites. The un-blinding-key will be sent to the project leaders in sealed envelopes. In this way, both the participants and principle investigator will be blinded throughout the study.

Study Groups

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Fish oils and dairy fats

Group Type EXPERIMENTAL

Fish oils and dairy fat

Intervention Type DIETARY_SUPPLEMENT

12-weeks, 3x per day

Fish oils and plant fats

Group Type PLACEBO_COMPARATOR

Fish oils and plant fat

Intervention Type DIETARY_SUPPLEMENT

12-weeks, 3x per day

Interventions

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Fish oils and dairy fat

12-weeks, 3x per day

Intervention Type DIETARY_SUPPLEMENT

Fish oils and plant fat

12-weeks, 3x per day

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University and Research

OTHER

Sponsor Role collaborator

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role collaborator

Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Schrauwen, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Wageningen University and Research

Wageningen, Gelderland, Netherlands

Site Status

Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL68966.068.19

Identifier Type: -

Identifier Source: org_study_id