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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194983
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
Wageningen University and Research
Netherlands Organisation for Scientific Research
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University

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.

Condition or disease Intervention/treatment Phase
Ageing Mitochondrial Function Physical Function Cognitive Function Dietary Supplement: Fish oils and dairy fat Dietary Supplement: Fish oils and plant fat Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish oils and dairy fats Dietary Supplement: Fish oils and dairy fat
12-weeks, 3x per day

Placebo Comparator: Fish oils and plant fats Dietary Supplement: Fish oils and plant fat
12-weeks, 3x per day




Primary Outcome Measures :
  1. Mitochondrial respiration [ Time Frame: 12 weeks ]
    Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second


Secondary Outcome Measures :
  1. Physical function [ Time Frame: 12 weeks ]
    Short physical Performance Battery (SPPB)

  2. Cognitive Function [ Time Frame: 12 Weeks ]
    Cambridge Neuropsychological Test Automated Battery (CANTAB)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194983


Contacts
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Contact: Ciaran E Fealy, PhD +31 43 388 5819 ciaran.fealy@maastrichtuniversity.nl

Locations
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Netherlands
Wageningen University and Research Recruiting
Wageningen, Gelderland, Netherlands, 6700AA
Contact: Marco Mensink, PhD    +31317482646      
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Ciaran E Fealy, PhD         
Principal Investigator: Patrick Schrauwen, PhD         
Sponsors and Collaborators
Maastricht University
Wageningen University and Research
Netherlands Organisation for Scientific Research
Top Institute Food and Nutrition
Investigators
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Principal Investigator: Patrick Schrauwen, PhD Maastricht University
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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT04194983    
Other Study ID Numbers: NL68966.068.19
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Ageing
Mitochondrial Function
Physical Function
Cognitive Function
Dietary Fat