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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04194983
• Other study ID #: NL68966.068.19
• Status: Terminated
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: November 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ageing
• Cognitive Function
• Mitochondrial Function
• Physical Function

Intervention

Dietary Supplement:
• Fish oils and dairy fat
12-weeks, 3x per day
• Fish oils and plant fat
12-weeks, 3x per day

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg
Netherlands	Wageningen University and Research	Wageningen	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University	Netherlands Organisation for Scientific Research, Top Institute Food and Nutrition, Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial respiration	Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second	12 weeks
Secondary	Physical function	Short physical Performance Battery (SPPB)	12 weeks
Secondary	Cognitive Function	Cambridge Neuropsychological Test Automated Battery (CANTAB)	12 Weeks