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ID
Source
Brief title
Health condition
cognitive impairment
Sponsors and support
Intervention
Outcome measures
Primary outcome
Episodic memory as measured with the RAVLT
Secondary outcome
cognitive functioning (episodic and working memory, attention, executive functioning, and psychomotor speed) as measured with a battery of cognitive tests, the evaluation of rumenic acid supplementation on anxiety, depressive symptoms, quality of life (measured with questionnaires), and plasma fatty acid status (measured in blood)
Background summary
Objective: The primary objective is to investigate the effect of 12 weeks of supplementation with 3.5g/day of rumenic acid on cognitive functioning in older men and women at risk of cognitive impairment. Secondary objectives include the assessment of the effect of rumenic acid supplementation on mental well-being, handgrip strength, hand joint discomfort, and plasma fatty acid levels.
Study design: Randomized, parallel, double-blind, placebo-controlled trial.
Study population: Elderly (≥ 65 years, n=52) at risk of cognitive impairment.
Intervention: Subjects will receive a daily dose of 3.5g rumenic acid divided over six capsules (intervention) or six placebo capsules (control).
Main study parameters/endpoints: The primary study parameter is episodic memory as measured with the RAVLT. Secondary parameters entail cognitive functioning (episodic and working memory, attention, executive functioning, and psychomotor speed) as measured with a battery of cognitive tests, the evaluation of rumenic acid supplementation on anxiety, depressive symptoms, quality of life (measured with questionnaires), and plasma fatty acid status (measured in blood).
Study objective
Daily supplementation of 3.5g RAR-CLA will slow down cognitive decline as compared to placebo
Study design
0 weeks and 12 weeks
Intervention
Subjects will receive a daily dose of 3.5g rumenic acid divided over six capsules (intervention) or six placebo capsules (control).
Inclusion criteria
• Aged ≥65 years
• At risk of cognitive impairment/ memory complaints
• Able to understand and perform the study procedures
Exclusion criteria
• Body Mass Index (BMI) >35 kg/m2
• Current use of medication belonging to the “sartans” or “glitazones”
• Current use of >500 mg/day of acetylsalicylic acid
• Current use of medication that affects inflammation (anti-inflammatory medication)
• Fish consumption of more than 1 serving per week
• Current or recent (<1 month) use of fish oil supplements
• Current or recent (<1 month) use of anti-inflammatory dietary supplements such as quercetin, curcumin, resveratrol, and/or other flavonoids
• Diabetes mellitus
• Having a disease which interferes with the effect of the RAR-CLA supplement and/or with the outcome measure (cognitive functioning) as judged by medical doctor
• Swallowing problems
• Current participation in other scientific research with the exception of EetMeetWeet!
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7598 |
| Other | METC-WU : 18/27 |