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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom, W1T 7HA
        • University Colllege London (ISEH)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chlorella Supplementation and Exercise
Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks
Dietary supplement: Chlorella supplementation
Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.
Other: 12 week cardiovascular training programme
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
Dietary supplement: Chlorella supplementation
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
Other: 12 week cardiovascular training programme
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).
Dietary supplement: Placebo Supplementation
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
Dietary supplement: Placebo Supplementation
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)
At baseline, week 6 and at week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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
Assessing changes in body composition variables using the Tanita. Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.
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
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
Changes in total vascular resistance
Time Frame: At baseline, week 6 and at week 12
Assessing changes in total vascular resistance (TVR) using the ABP-Monitor Mobil-O-Graph NG.
At baseline, week 6 and at week 12
Changes in augmentation index
Time Frame: At baseline, week 6 and at week 12
Assessing changes in augmentation index (Alx) using the ABP-Monitor Mobil-O-Graph NG.
At baseline, week 6 and at week 12
Changes in augmentation pressure
Time Frame: At baseline, week 6 and at week 12
Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.
At baseline, week 6 and at week 12
Changes in lactate
Time Frame: At baseline, week 6 and at week 12
Assessing changes in lactate at rest, peak, +5mins post, +10mins post, +30mins post
At baseline, week 6 and at week 12
Changes in biomarkers for brain health
Time Frame: At baseline, week 6 and at week 12
Assessing changes in Brain-Derived Neurotrophic Factor (before exercise at rest and 30-mins post peak exercise)
At baseline, week 6 and at week 12
Changes in Nitrate/Nitrite
Time Frame: At baseline, week 6 and at week 12
Assessing changes in plasma Nitrate and Nitrite concentrations
At baseline, week 6 and at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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