AgeingNCT04194983
The Effect of Fish Oils With Dairy or Plant Based Lipids on Mitochondrial and Physical, and Cognitive Function, in Elderly Humans
A study testing Fish oils and dairy fat and Fish oils and plant fat in people with Ageing and Mitochondrial Function, run by Maastricht University at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing, Mitochondrial Function, Physical Function
- What is being tested?
- Fish oils and dairy fat and Fish oils and plant fat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Dec 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University
Maastricht, Limburg, 6200 MD
Wageningen University and Research
Wageningen, Gelderland, 6700AA
About this study
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
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.
Read the 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.
- Conditions
- Ageing, Mitochondrial Function, Physical Function, Cognitive Function
- Being tested
- Fish oils and dairy fat, Fish oils and plant fat
- Keywords
- Ageing, Mitochondrial Function, Physical Function, Cognitive Function, Dietary Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oils and dairy fatDietary supplement
12-weeks, 3x per day
Fish oils and plant fatDietary supplement
12-weeks, 3x per day
| Study group | Role | What they receive |
|---|---|---|
| Fish oils and dairy fats | Experimental | Not described Receives: Dietary Supplement: Fish oils and dairy fat |
| Fish oils and plant fats | Placebo comparator | Not described Receives: Dietary Supplement: Fish oils and plant fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial respiration
Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second
Measured: 12 weeks
Secondary outcomes (2)
Physical function
Short physical Performance Battery (SPPB)
Measured: 12 weeks
Cognitive Function
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start11 Dec 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: due to COVID-19 and lack of financial means to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Netherlands Organisation for Scientific Research, Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Patrick Schrauwen, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194983
- Sponsor's protocol ID
- NL68966.068.19
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04194983
- Acronym / sponsor ID
- NL68966.068.19
- Conditions
- Ageing, Mitochondrial Function, Physical Function, Cognitive Function
- Keywords
- Ageing, Mitochondrial Function, Physical Function, Cognitive Function, Dietary Fat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to COVID-19 and lack of financial means to continue
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Netherlands Organisation for Scientific Research, Top Institute Food and Nutrition
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oils and dairy fat12-weeks, 3x per day | Dietary supplement | Fish oils and dairy fats |
| Fish oils and plant fat12-weeks, 3x per day | Dietary supplement | Fish oils and plant fats |
Primary outcome
Mitochondrial respiration
Time frame: 12 weeks
Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second
2 secondary outcomes
Physical function
Time frame: 12 weeks
Cognitive Function
Time frame: 12 Weeks
Results and safety
The study was stopped early (reason given: due to COVID-19 and lack of financial means to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Schrauwen, PhD principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oils and dairy fat and Fish oils and plant fat in people with Ageing and Mitochondrial Function, run by Maastricht University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to COVID-19 and lack of financial means to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial respiration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.