SedentaryNCT05639634
The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
A study testing Chlorella supplementation and 12 week cardiovascular training programme in people with Sedentary and Overweight, run by University College, London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Overweight
- What is being tested?
- Chlorella supplementation and 12 week cardiovascular training programme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2023to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals taking blood thinners.
- Known allergies to algae/mould and iodine.
- Taking immunosuppressant medication
- Regularly ingesting algae
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Sedentary, Overweight
- Being tested
- Chlorella supplementation, 12 week cardiovascular training programme, Placebo Supplementation
- Medical subject headings
- Sedentary Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorella supplementationDietary supplement
Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.
12 week cardiovascular training programmeOther
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).
Placebo SupplementationDietary supplement
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chlorella Supplementation and Exercise | Experimental | Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks Receives: Dietary Supplement: Chlorella supplementation; Other: 12 week cardiovascular training programme |
| Chlorella Supplementation | Experimental | Supplementation with Chlorella (1.5 g/d) only for 12 weeks. No exercise programme Receives: Dietary Supplement: Chlorella supplementation |
| Placebo Supplementation and Exercise | Placebo comparator | Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks Receives: Other: 12 week cardiovascular training programme; Dietary Supplement: Placebo Supplementation |
| Placebo Supplementation | Placebo comparator | Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) only for 12 weeks. No exercise programme Receives: Dietary Supplement: Placebo Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiovascular fitness (VO2max)
Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test.
Measured: At baseline, week 6 and at week 12
Changes in blood lipid profiling
Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)
Measured: At baseline, week 6 and at week 12
Secondary outcomes (16)
Changes in cognitive function (simple reaction time)
Assessing changes in simple reaction time (m/s \& number of errors) using the Gorilla Experiment Builder on a laptop.
Measured: At baseline, week 6 and at week 12 (before and after exercise)
Changes in cognitive function (inhibition)
Assessing changes in inhibition (m/s \& number of errors) using the Gorilla Experiment Builder on a laptop.
Measured: At baseline, week 6 and at week 12 (before and after exercise)
Changes in cognitive function (endogenous and exogenous attending)
Assessing changes in endogenous and exogenous attending (m/s \& number of errors) using the Gorilla Experiment Builder on a laptop.
Measured: At baseline, week 6 and at week 12 (before and after exercise)
Changes in cognitive function (context memory)
Assessing changes in source and context memory (m/s \& number of errors) using the Gorilla Experiment Builder on a laptop. spatial anticipation
Measured: At baseline, week 6 and at week 12 (before and after exercise)
Changes in cognitive function (spatial anticipation)
Assessing changes in spatial anticipation (m/s \& number of errors) using the Gorilla Experiment Builder on a laptop.
Measured: At baseline, week 6 and at week 12 (before and after exercise)
Changes in body composition variables
Assessing changes in body composition variables using the Tanita. Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.
Measured: At baseline, week 6 and at week 12
Changes in body composition variables (fat & lean mass percentage)
Assessing changes in body fat mass (Body Fat mass %) and lean mass in percentage (Lean mass %) using the Tanita.
Measured: At baseline, week 6 and at week 12
Changes in body composition variables (fat free and muscle mass)
Assessing changes in fat free mass (kg) and muscle mass (kg) using the Tanita.
Measured: At baseline, week 6 and at week 12
Changes in blood pressure
Assessing changes in blood pressure (mmHg). Systolic and diastolic, using the ABP-Monitor Mobil-O-Graph NG
Measured: At baseline, week 6 and at week 12
Changes in pulse wave velocity
Assessing changes in pulse wave velocity (PWV) using the ABP-Monitor Mobil-O-Graph NG.
Measured: At baseline, week 6 and at week 12
Changes in total vascular resistance
Assessing changes in total vascular resistance (TVR) using the ABP-Monitor Mobil-O-Graph NG.
Measured: At baseline, week 6 and at week 12
Changes in augmentation index
Assessing changes in augmentation index (Alx) using the ABP-Monitor Mobil-O-Graph NG.
Measured: At baseline, week 6 and at week 12
Changes in augmentation pressure
Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.
Measured: At baseline, week 6 and at week 12
Changes in lactate
Assessing changes in lactate at rest, peak, +5mins post, +10mins post, +30mins post
Measured: At baseline, week 6 and at week 12
Changes in biomarkers for brain health
Assessing changes in Brain-Derived Neurotrophic Factor (before exercise at rest and 30-mins post peak exercise)
Measured: At baseline, week 6 and at week 12
Changes in Nitrate/Nitrite
Assessing changes in plasma Nitrate and Nitrite concentrations
Measured: At baseline, week 6 and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start11 Jan 2023
- Primary completion1 Aug 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedentaryStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Gurney, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639634
- Sponsor's protocol ID
- 21745/002
- Status last verified
- Jan 2024
- First submitted
- 24 Oct 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
- ClinicalTrials.gov ID
- NCT05639634
- Acronym / sponsor ID
- 21745/002
- Conditions
- Sedentary, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chlorella Supplementation and Exercise | Experimental | Dietary Supplement: Chlorella supplementation, Other: 12 week cardiovascular training programmeSupplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks |
| Chlorella Supplementation | Experimental | Dietary Supplement: Chlorella supplementationSupplementation with Chlorella (1.5 g/d) only for 12 weeks. No exercise programme |
| Placebo Supplementation and Exercise | Placebo comparator | Other: 12 week cardiovascular training programme, Dietary Supplement: Placebo SupplementationSupplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo SupplementationSupplementation with Placebo - microcrystalline cellulose (1.5 g/d) only for 12 weeks. No exercise programme |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Individuals taking blood thinners.
- Known allergies to algae/mould and iodine.
- Taking immunosuppressant medication
- Regularly ingesting algae
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorella supplementationSupplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks. | Dietary supplement | Chlorella Supplementation, Chlorella Supplementation and Exercise |
| 12 week cardiovascular training programmeParticipants 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). | Other | Chlorella Supplementation and Exercise, Placebo Supplementation and Exercise |
| Placebo SupplementationSupplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks. | Dietary supplement | Placebo Supplementation, Placebo Supplementation and Exercise |
Primary outcome
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.
Changes in blood lipid profiling
Time frame: At baseline, week 6 and at week 12
Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)
16 secondary outcomes
Changes in cognitive function (simple reaction time)
Time frame: 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)
Changes in cognitive function (endogenous and exogenous attending)
Time frame: 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)
Changes in cognitive function (spatial anticipation)
Time frame: At baseline, week 6 and at week 12 (before and after exercise)
Changes in body composition variables
Time frame: 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
Changes in body composition variables (fat free and muscle mass)
Time frame: At baseline, week 6 and at week 12
Changes in blood pressure
Time frame: At baseline, week 6 and at week 12
Changes in pulse wave velocity
Time frame: At baseline, week 6 and at week 12
Changes in total vascular resistance
Time frame: At baseline, week 6 and at week 12
Changes in augmentation index
Time frame: At baseline, week 6 and at week 12
Changes in augmentation pressure
Time frame: At baseline, week 6 and at week 12
Changes in lactate
Time frame: At baseline, week 6 and at week 12
Changes in biomarkers for brain health
Time frame: At baseline, week 6 and at week 12
Changes in Nitrate/Nitrite
Time frame: At baseline, week 6 and at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Gurney principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorella supplementation and 12 week cardiovascular training programme in people with Sedentary and Overweight, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiovascular fitness (VO2max) (time frame: At baseline, week 6 and at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.