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

Sponsor
University College, London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05639634
Collaborator
(none)
60
1
4
32
1.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Chlorella supplementation
  • Other: 12 week cardiovascular training programme
  • Dietary Supplement: Placebo Supplementation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double
Primary Purpose:
Treatment
Official Title:
The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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 3 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 - micro crystalline 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 3 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 - micro crystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.

Placebo Comparator: Placebo Supplementation

Supplementation with Placebo - micro crystalline cellulose (1.5 g/d) only for 12 weeks. No exercise programme

Dietary Supplement: Placebo Supplementation
Supplementation with Placebo - micro crystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. Changes in cardiovascular fitness (VO2max) [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 [At baseline, week 6 and at week 12]

    Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)

Secondary Outcome Measures

  1. Changes in cognitive function (simple reaction time) [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) [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) [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) [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) [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 [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) [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) [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 [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 [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 [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 [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 [At baseline, week 6 and at week 12]

    Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Colllege London (ISEH) London United Kingdom W1T 7HA

Sponsors and Collaborators

  • University College, London

Investigators

  • Principal Investigator: Tom Gurney, University College, London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT05639634
Other Study ID Numbers:
  • 21745/002
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2022