- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05639634
The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
January 30, 2024 updated by: University College, London
Algae are an emerging functional food source that are gaining traction and popularity in biopharmaceutical, nutraceutical, and biotechnology industries.
They are a diverse and complex species that comprise an abundant breadth of micronutrients (multiple vitamins, minerals, fatty acids, and amino acids) that can possibly promote human health.
One such popular algae is chlorella, a unicellular dark green organism, which can be readily bought in health stores worldwide.
Although there is some promising data to suggest chlorella supplementation can alleviate cardiovascular risk factors and improve VO2max from supplementation alone, an area which has particularly limited existing literature is the possible ergogenic and health influence of chlorella supplementation combined with a controlled training programme in sedentary and overweight populations.
Given that such populations are susceptible to increased risk of developing associated diseases (cardiovascular disease, diabetes, hypertension) and possess poor diets, there is a need to investigate the possible synergistic effect of a training programme and supplementation of algae further.
Furthermore, there is growing evidence to suggest that supplementation with algae may have a beneficial effect on cognitive function, primarily owed to antioxidant and anti-inflammatory mechanisms.
Therefore, the purpose of this study aims to assess the efficacy of chlorella supplementation on VO2max, blood lipid profiles, cognitive function and body composition following a 12-week training programme.
Briefly, in a double blind, randomised, placebo-controlled trial, participants will be randomly allocated into 1 of 4 groups (A.
Exercise + Chlorella, B. Exercise + Placebo, C. Control + Chlorella, D. Control + Placebo).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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London, United Kingdom, W1T 7HA
- University Colllege London (ISEH)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 18-50
- Classified a sedentary (<30 minutes of moderate intensity exercise for <3 days per week for 3 months) and/or overweight (BMI = 25 +)
- Be willing to complete a 12-week training programme
Exclusion Criteria:
- Individuals taking blood thinners.
- Known allergies to algae/mould and iodine.
- Taking immunosuppressant medication
- Regularly ingesting algae
- Smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chlorella Supplementation and Exercise
Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks
|
Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.
Participants will be asked to complete a 12 week cycling training programme.
This will consist of 4 X 50 min sessions per week.
Each exercise session will include a warm-up phase (~ 5 min), a main physical conditioning phase (~ 40 min), and a cool-down phase (~ 5 min).
|
|
Experimental: Chlorella Supplementation
Supplementation with Chlorella (1.5 g/d) only for 12 weeks.
No exercise programme
|
Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.
|
|
Placebo Comparator: Placebo Supplementation and Exercise
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks
|
Participants will be asked to complete a 12 week cycling training programme.
This will consist of 4 X 50 min sessions per week.
Each exercise session will include a warm-up phase (~ 5 min), a main physical conditioning phase (~ 40 min), and a cool-down phase (~ 5 min).
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.
|
|
Placebo Comparator: Placebo Supplementation
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) only for 12 weeks.
No exercise programme
|
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in cardiovascular fitness (VO2max)
Time Frame: At baseline, week 6 and at week 12
|
Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test.
|
At baseline, week 6 and at week 12
|
|
Changes in blood lipid profiling
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)
|
At baseline, week 6 and at week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in cognitive function (simple reaction time)
Time Frame: At baseline, week 6 and at week 12 (before and after exercise)
|
Assessing changes in simple reaction time (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
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At baseline, week 6 and at week 12 (before and after exercise)
|
|
Changes in cognitive function (inhibition)
Time Frame: At baseline, week 6 and at week 12 (before and after exercise)
|
Assessing changes in inhibition (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
|
At baseline, week 6 and at week 12 (before and after exercise)
|
|
Changes in cognitive function (endogenous and exogenous attending)
Time Frame: At baseline, week 6 and at week 12 (before and after exercise)
|
Assessing changes in endogenous and exogenous attending (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
|
At baseline, week 6 and at week 12 (before and after exercise)
|
|
Changes in cognitive function (context memory)
Time Frame: At baseline, week 6 and at week 12 (before and after exercise)
|
Assessing changes in source and context memory (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
spatial anticipation
|
At baseline, week 6 and at week 12 (before and after exercise)
|
|
Changes in cognitive function (spatial anticipation)
Time Frame: At baseline, week 6 and at week 12 (before and after exercise)
|
Assessing changes in spatial anticipation (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
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At baseline, week 6 and at week 12 (before and after exercise)
|
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Changes in body composition variables
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in body composition variables using the Tanita.
Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.
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At baseline, week 6 and at week 12
|
|
Changes in body composition variables (fat & lean mass percentage)
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in body fat mass (Body Fat mass %) and lean mass in percentage (Lean mass %) using the Tanita.
|
At baseline, week 6 and at week 12
|
|
Changes in body composition variables (fat free and muscle mass)
Time Frame: At baseline, week 6 and at week 12
|
Assessing changes in fat free mass (kg) and muscle mass (kg) using the Tanita.
|
At baseline, week 6 and at week 12
|
|
Changes in blood pressure
Time Frame: At baseline, week 6 and at week 12
|
Assessing changes in blood pressure (mmHg).
Systolic and diastolic, using the ABP-Monitor Mobil-O-Graph NG
|
At baseline, week 6 and at week 12
|
|
Changes in pulse wave velocity
Time Frame: At baseline, week 6 and at week 12
|
Assessing changes in pulse wave velocity (PWV) using the ABP-Monitor Mobil-O-Graph NG.
|
At baseline, week 6 and at week 12
|
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Changes in total vascular resistance
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in total vascular resistance (TVR) using the ABP-Monitor Mobil-O-Graph NG.
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At baseline, week 6 and at week 12
|
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Changes in augmentation index
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in augmentation index (Alx) using the ABP-Monitor Mobil-O-Graph NG.
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At baseline, week 6 and at week 12
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Changes in augmentation pressure
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.
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At baseline, week 6 and at week 12
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Changes in lactate
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in lactate at rest, peak, +5mins post, +10mins post, +30mins post
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At baseline, week 6 and at week 12
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Changes in biomarkers for brain health
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in Brain-Derived Neurotrophic Factor (before exercise at rest and 30-mins post peak exercise)
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At baseline, week 6 and at week 12
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Changes in Nitrate/Nitrite
Time Frame: At baseline, week 6 and at week 12
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Assessing changes in plasma Nitrate and Nitrite concentrations
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At baseline, week 6 and at week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tom Gurney, University College, London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2023
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
September 23, 2023
Study Registration Dates
First Submitted
October 24, 2022
First Submitted That Met QC Criteria
November 28, 2022
First Posted (Actual)
December 6, 2022
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21745/002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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