Clinical trial NCT05639634: The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
Official title: The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary
Overweight
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Changes in cardiovascular fitness (VO2max)
timeFrame: At baseline, week 6 and at week 12
measure: Changes in blood lipid profiling
timeFrame: At baseline, week 6 and at week 12
Secondary outcomes:
measure: Changes in cognitive function (simple reaction time)
timeFrame: At baseline, week 6 and at week 12 (before and after exercise)
measure: Changes in cognitive function (inhibition)
timeFrame: At baseline, week 6 and at week 12 (before and after exercise)
measure: Changes in cognitive function (endogenous and exogenous attending)
timeFrame: At baseline, week 6 and at week 12 (before and after exercise)
measure: Changes in cognitive function (context memory)
timeFrame: At baseline, week 6 and at week 12 (before and after exercise)
measure: Changes in cognitive function (spatial anticipation)
timeFrame: At baseline, week 6 and at week 12 (before and after exercise)
measure: Changes in body composition variables
timeFrame: At baseline, week 6 and at week 12
measure: Changes in body composition variables (fat & lean mass percentage)
timeFrame: At baseline, week 6 and at week 12
measure: Changes in body composition variables (fat free and muscle mass)
timeFrame: At baseline, week 6 and at week 12
measure: Changes in blood pressure
timeFrame: At baseline, week 6 and at week 12
measure: Changes in pulse wave velocity
timeFrame: At baseline, week 6 and at week 12
measure: Changes in total vascular resistance
timeFrame: At baseline, week 6 and at week 12
measure: Changes in augmentation index
timeFrame: At baseline, week 6 and at week 12
measure: Changes in augmentation pressure
timeFrame: At baseline, week 6 and at week 12
measure: Changes in lactate
timeFrame: At baseline, week 6 and at week 12
measure: Changes in biomarkers for brain health
timeFrame: At baseline, week 6 and at week 12
measure: Changes in Nitrate/Nitrite
timeFrame: At baseline, week 6 and at week 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University Colllege London (ISEH)
Study officials:
affiliation: University College, London
name: Tom Gurney
role: PRINCIPAL_INVESTIGATOR
References: