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

NCT05639634 | Completed

• 1 other identifier: 21745/002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Sedentary; Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Changes in cognitive function (simple reaction time)

  At baseline, week 6 and at week 12 (before and after exercise)

• Changes in cognitive function (inhibition)

  At baseline, week 6 and at week 12 (before and after exercise)

• Changes in cognitive function (endogenous and exogenous attending)

  At baseline, week 6 and at week 12 (before and after exercise)

• Changes in cognitive function (context memory)

  At baseline, week 6 and at week 12 (before and after exercise)

• Changes in cognitive function (spatial anticipation)

  At baseline, week 6 and at week 12 (before and after exercise)

Study Arms (4)

Chlorella Supplementation and Exercise

EXPERIMENTAL

Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks

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

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

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

Dietary Supplement: Placebo Supplementation

Interventions

Chlorella supplementation DIETARY_SUPPLEMENT

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

Chlorella Supplementation; Chlorella Supplementation and Exercise

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).

Chlorella Supplementation and Exercise; Placebo Supplementation and Exercise

Placebo Supplementation DIETARY_SUPPLEMENT

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

Placebo Supplementation; Placebo Supplementation and Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals taking blood thinners.
• Known allergies to algae/mould and iodine.
• Taking immunosuppressant medication
• Regularly ingesting algae
• Smokers

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University Colllege London (ISEH)

London, W1T 7HA, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Gurney

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 6, 2022
• Study Start: January 11, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 23, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)