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

Study Overview
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Brief Summary
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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).

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

Conditions
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Sedentary, Overweight

Intervention / Treatment
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* Dietary Supplement: Chlorella supplementation
* Other: 12 week cardiovascular training programme
* Dietary Supplement: Placebo Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorella Supplementation and Exercise<br>Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks | Dietary Supplement: Chlorella supplementation<br>* Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.<br>Other: 12 week cardiovascular training programme<br>* 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).<br>|
| Experimental: Chlorella Supplementation<br>Supplementation with Chlorella (1.5 g/d) only for 12 weeks. No exercise programme | Dietary Supplement: Chlorella supplementation<br>* Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.<br>|
| Placebo Comparator: Placebo Supplementation and Exercise<br>Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks | Other: 12 week cardiovascular training programme<br>* 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).<br>Dietary Supplement: Placebo Supplementation<br>* Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.<br>|
| Placebo Comparator: Placebo Supplementation<br>Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) only for 12 weeks. No exercise programme | Dietary Supplement: Placebo Supplementation<br>* Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiovascular fitness (VO2max) | 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 | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG. | At baseline, week 6 and at week 12 | 
| Changes in lactate | 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 | 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 | Assessing changes in plasma Nitrate and Nitrite concentrations | At baseline, week 6 and at week 12 |