- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936202
Effects of Spirulina Supplementation on Mental Health in Healthy Adults
Spirulina platensis is a form of cyanobacteria, a blue-green algae, and is a superfood most known for being rich in protein, vitamins and minerals, and healthful phytochemicals. Spirulina supports brain health through neuroprotection offered by its antioxidants, anti-inflammatory properties, and hormone regulation.
The aim of this study is to supplement healthy adults from a campus community with 3g of spirulina, daily, for 8 weeks to improve mood and mental acuity in comparison to receiving a placebo.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Spirulina is nutrient-dense with vitamins and minerals which provide antioxidants and anti-inflammatory mechanisms to help reduce oxidative stress and ROS activity. Preclinical studies have indicated Spirulina can reduce inflammatory cytokines, such as IL-1β, and reverse stress responses and oxidative damage in BDNF, nuclear factor erythroid 2-related factor (NRF2), and ultimately the phosphorylation of protein-kinase B (AKT), which promotes cell growth. In addition to these benefits, fatty acids, gamma-linolenic acid (GLA) and glycolipids, support gut health and the immune system. In combination, all these nutrients help increase neuroprotection and brain health.
It is evident that Spirulina supports brain health through neuroprotection, antioxidants, anti-inflammatory properties, and hormone regulation. Research supports Spirulina reversing neurodegenerative diseases due to several of these beneficial properties. There have been many studies that utilize Spirulina to improve cognitive function in Alzheimer's Disease, Parkinson's Disease, ulcerative colitis, IBD, fibromyalgia and even in TBI and Ischemic stroke.
Although many of these diseases have depressive symptoms, few of these studies have evaluated the impact of Spirulina on mood. Furthermore, no studies have been conducted relating depression and the cyanobacteria. It is possible that Spirulina supplements can be used to reduce feelings of hopelessness and lack of energy, by providing additional vitamins, minerals, amino acids, and fatty acids, on a daily basis. This study aims to compare spirulina and its improvement on mood, in health college students, by daily supplementation of 3g of Spirulina over a span of 8 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carol Johnston, PhD
- Phone Number: 16024962539
- Email: carol.johnston@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- 850 PBC
-
Contact:
- Carol Johnston
- Phone Number: 602-496-2539
- Email: carol.johnston@asu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy adults
- ages 18-65
- no underlying chronic disease or acute conditions
- no autoimmune conditions
- do not consume alcohol in excess, smoke, use recreational drugs
- does not follow restrictive diets
- will be recruited from the ASU university campus.
Exclusion Criteria:
- not have been clinically diagnosed with depression
- not taking antidepressants, anxiety, or stress medications, or any other medications
- drugs, or supplements that could influence mental capacities
- not pregnant or breastfeeding
- not a competitive athlete
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: spirulina capsules
six capsules daily (totaling 3 g)
|
active intervention
|
|
Placebo Comparator: Placebo
Pea powder - 6 capsules daily
|
no active ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POMS (profile of mood states questionnaire)
Time Frame: conducted at baseline and at week 8 (study's end)
|
A validated measure consisting of 65 brief phrases, asking how they have personally felt over the last week, including today.
The participants were asked to carefully rate their response on a 5-point Likert scale, ranging from 'not at all' to 'extremely'.
|
conducted at baseline and at week 8 (study's end)
|
|
Trail Making Test
Time Frame: conducted at baseline and at week 8 (study's end)
|
The TMT consists of two iterations - versions A and B - and brief samples of each will be provided for the participant to practice prior to the longer, scored version.
This is a timed paper and pencil test requiring the participant to connect a series of numbers and/or letters that are randomly arranged.
|
conducted at baseline and at week 8 (study's end)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00021993
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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