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NCT Number: NCT05639634

The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme

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).

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Key information

Conditions

Sedentary Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Colllege London (ISEH)

London, W1T 7HA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorella supplementation

Dietary Supplement

Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.

12 week cardiovascular training programme

Other

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 supplementation

Dietary Supplement

Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  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.

  13. 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.

  14. 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

  15. 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)

  16. Changes in Nitrate/Nitrite

    Time frame: At baseline, week 6 and at week 12

    Assessing changes in plasma Nitrate and Nitrite concentrations

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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