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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

M

Maastricht University

Status

Terminated

Conditions

Cognitive Function
Physical Function
Ageing
Mitochondrial Function

Treatments

Dietary Supplement: Fish oils and dairy fat
Dietary Supplement: Fish oils and plant fat

Study type

Interventional

Funder types

Other

Identifiers

NCT04194983
NL68966.068.19

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

25 participants in 2 patient groups, including a placebo group

Fish oils and dairy fats
Experimental group
Treatment:
Dietary Supplement: Fish oils and dairy fat
Fish oils and plant fats
Placebo Comparator group
Treatment:
Dietary Supplement: Fish oils and plant fat

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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