The aim of the present study is to investigate the effect of a microalgae (Hematoccocus pluvialis) on the stress response and mental wellbeing in jong adults.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
stress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to assess the effect of 8 weeks of supplementing daily
270 mg microalgae powder on the stress response
Secondary outcome
The secondary objective are to study the effects on mental wellbeing with the
aid of questionnaires and measuring physiological markers such as BDNF and
GABA. An exploratory study objective ais to study the effect on the microalgae
supplementation on cognition.
Background summary
On a global scale, individuals experience more worries and stress compared to
the last couple of years. This is a major concern because increased stress
levels can alter hormonal release, which could have negative impacts on health.
The supplementation of a whole microalgae powder, rich in multiple bioactive
compounds such as astaxanthin, can be an effective strategy to target stress
and mental wellbeing, due to its potential to attenuate cortisol release, the
stress hormone.
Study objective
The aim of the present study is to investigate the effect of a microalgae
(Hematoccocus pluvialis) on the stress response and mental wellbeing in jong
adults.
Study design
A randomized, double-blind, placebo-controlled, parallel trial
Intervention
Participants will ingest daily with breakfast 270 mg microalgae powder or
placebo capsules for 8 weeks
Study burden and risks
The total study duration will be 8 weeks. During the study, blood samples will
be collected (<500 mL in total), which occasionally may cause a hematoma or
bruise. Other measurements are not expected to cause side effects. Subjects
will have a time investment of ± 13.5 hours (screening, three test days,
preparation at home).
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Listed location countries
Age
Inclusion criteria
• Age 18-35 years old
• BMI between 18 and 30 kg/m2
• Willing to abstain from nutritional supplements known to affect the study
outcome (e.g., ashwagandha, omega-3 fatty acids, rhodiola, vitamin c, and
magnesium)
Exclusion criteria
• Currently smoking or quitted smoking in the past year
• Allergy to an ingredient of the product
• Having donated blood within one month prior to the start of the study, or
planning to donate blood during the study
• Use of medication known to affect the outcomes of the study
• Irregular menstrual cycle
• Adrenal gland diseases (such as Addison*s disease and Cushing*s syndrome)
• Prader-Willi syndrome
• Known pregnancy or lactation
• Shift workers
• Major psychiatric/mental health disorders (e.g., depression, anxiety,
post-traumatic stress)
• Diabetes
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCTnognietbekend |
| CCMO | NL86217.068.24 |