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

NCT04194983 | Terminated

• 1 other identifier: NL68966.068.19
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ageing; Mitochondrial Function; Physical Function; Cognitive Function

Keywords

Ageing; Mitochondrial Function; Physical Function; Cognitive Function; Dietary Fat

Outcome Measures

Primary Outcomes (1)

• Mitochondrial respiration

  Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second

  12 weeks

Secondary Outcomes (2)

• Physical function

  12 weeks

• Cognitive Function

  12 Weeks

Study Arms (2)

Fish oils and dairy fats

EXPERIMENTAL

Dietary Supplement: Fish oils and dairy fat

Fish oils and plant fats

PLACEBO COMPARATOR

Dietary Supplement: Fish oils and plant fat

Interventions

Fish oils and dairy fat DIETARY_SUPPLEMENT

12-weeks, 3x per day

Fish oils and dairy fats

Fish oils and plant fat DIETARY_SUPPLEMENT

12-weeks, 3x per day

Fish oils and plant fats

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead
• Wageningen University and Research: collaborator
• Netherlands Organisation for Scientific Research: collaborator
• Top Institute Food and Nutrition: collaborator

Study Sites (2)

Wageningen University and Research

Wageningen, Gelderland, 6700AA, Netherlands

Location

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Patrick Schrauwen, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, double-blind, randomised, controlled, parallel trial, where fish oils combined with dairy or plant based fat supplements are consumed for 12-weeks.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 11, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

NL (2)