The primary objective is to investigate the effect of 12 weeks of supplementation with 3.5g/day of rumenic acid on episodic memory in older men and women at risk of cognitive impairment. Secondary objectives include working memory, attention,…
ID
Source
Brief title
Condition
- Other condition
- Central nervous system infections and inflammations
Synonym
Health condition
cognitieve stoornis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the performance on episodic memory.
Secondary outcome
Secondary parameters entail 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 fatty acid status (measured
in blood).
Background summary
The ageing population is rapidly growing, leading to a steep increase in
prevalence of cognitive decline. Cognitive decline is a major health threat and
entails serious personal and economic consequences. Unfortunately, to date it
is impossible to reverse the process of cognitive decline. This highlights the
need for better understanding on how to prevent and slow down this process. As
ageing and cognitive decline are associated with increased levels of
inflammation, nutritional compounds that exhibit anti-inflammatory properties
may propose a solution. Rumenic acid, a conjugated linoleic acid, has shown
anti-inflammatory effects in several human intervention studies. Besides, a
first intervention study investigating the effect of rumenic acid
supplementation on cognitive performance has shown promising results. However,
more research is needed to further investigate the potential beneficial effect
of rumenic acid on cognition by means of well-designed intervention studies.
The authors of the first intervention study specifically recommend future
studies with a duration longer than 8 weeks and performed in elderly with
impaired cognitive functioning.
Study objective
The primary objective is to investigate the effect of 12 weeks of
supplementation with 3.5g/day of rumenic acid on episodic memory in older men
and women at risk of cognitive impairment. Secondary objectives include working
memory, attention, executive functioning, and psychomotor speed, the assessment
of the effect of rumenic acid supplementation on mental well-being, handgrip
strength, hand joint discomfort, and fatty acid blood levels.
Study design
Randomized, parallel, double-blind, placebo-controlled trial.
Intervention
Subjects will receive a daily dose of 3.5g rumenic acid divided over six
capsules (intervention) or six placebo capsules (control).
Study burden and risks
Burdens that research subjects may experience include time investment
(approximately 0.5 hour for the screening and 2 hours on each of the 2
measurement days) and daily consumption of the rumenic acid supplement or
placebo. Both supplements are safe for human use. During each test session, a
1-hour cognitive test battery will be performed which may be experienced as
tiresome. In addition, a total of 40 mL of blood will be sampled via
venepuncture. This may lead to minor discomfort and can cause small hematomas
to appear. Furthermore, research subjects have to come in fasting state which
may give some discomfort. However, breakfast will be offered afterwards.
Museumlaan 16
Koog aan de Zaan 1541LP
NL
Museumlaan 16
Koog aan de Zaan 1541LP
NL
Listed location countries
Age
Inclusion criteria
- Aged 65 years or older
- 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66867.081.18 |
| Other | NL7598 |