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

Primary Purpose

Sedentary, Overweight

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Chlorella supplementation
12 week cardiovascular training programme
Placebo Supplementation
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedentary

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Colllege London (ISEH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Chlorella Supplementation and Exercise

Chlorella Supplementation

Placebo Supplementation and Exercise

Placebo Supplementation

Arm Description

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

Supplementation with Chlorella (1.5 g/d) only for 12 weeks. No exercise programme

Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks

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

Outcomes

Primary Outcome Measures

Changes in cardiovascular fitness (VO2max)
Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test.
Changes in blood lipid profiling
Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)

Secondary Outcome Measures

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.
Changes in cognitive function (inhibition)
Assessing changes in inhibition (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
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.
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
Changes in cognitive function (spatial anticipation)
Assessing changes in spatial anticipation (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
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.
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.
Changes in body composition variables (fat free and muscle mass)
Assessing changes in fat free mass (kg) and muscle mass (kg) using the Tanita.
Changes in blood pressure
Assessing changes in blood pressure (mmHg). Systolic and diastolic, using the ABP-Monitor Mobil-O-Graph NG
Changes in pulse wave velocity
Assessing changes in pulse wave velocity (PWV) using the ABP-Monitor Mobil-O-Graph NG.
Changes in total vascular resistance
Assessing changes in total vascular resistance (TVR) using the ABP-Monitor Mobil-O-Graph NG.
Changes in augmentation index
Assessing changes in augmentation index (Alx) using the ABP-Monitor Mobil-O-Graph NG.
Changes in augmentation pressure
Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.
Changes in lactate
Assessing changes in lactate at rest, peak, +5mins post, +10mins post, +30mins post
Changes in biomarkers for brain health
Assessing changes in Brain-Derived Neurotrophic Factor (before exercise at rest and 30-mins post peak exercise)
Changes in Nitrate/Nitrite
Assessing changes in plasma Nitrate and Nitrite concentrations

Full Information

First Posted
October 24, 2022
Last Updated
March 14, 2023
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT05639634
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorella Supplementation and Exercise
Arm Type
Experimental
Arm Description
Supplementation with Chlorella (1.5 g/d) with a physical exercise program for 12 weeks
Arm Title
Chlorella Supplementation
Arm Type
Experimental
Arm Description
Supplementation with Chlorella (1.5 g/d) only for 12 weeks. No exercise programme
Arm Title
Placebo Supplementation and Exercise
Arm Type
Placebo Comparator
Arm Description
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) with a physical exercise program for 12 weeks
Arm Title
Placebo Supplementation
Arm Type
Placebo Comparator
Arm Description
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) only for 12 weeks. No exercise programme
Intervention Type
Dietary Supplement
Intervention Name(s)
Chlorella supplementation
Intervention Description
Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.
Intervention Type
Other
Intervention Name(s)
12 week cardiovascular training programme
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Supplementation
Intervention Description
Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.
Primary Outcome Measure Information:
Title
Changes in cardiovascular fitness (VO2max)
Description
Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in blood lipid profiling
Description
Assessing changes in blood lipids (Triglycerides, cholesterol, low-density lipoprotein, High-density lipoprotein)
Time Frame
At baseline, week 6 and at week 12
Secondary Outcome Measure Information:
Title
Changes in cognitive function (simple reaction time)
Description
Assessing changes in simple reaction time (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
Time Frame
At baseline, week 6 and at week 12 (before and after exercise)
Title
Changes in cognitive function (inhibition)
Description
Assessing changes in inhibition (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
Time Frame
At baseline, week 6 and at week 12 (before and after exercise)
Title
Changes in cognitive function (endogenous and exogenous attending)
Description
Assessing changes in endogenous and exogenous attending (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
Time Frame
At baseline, week 6 and at week 12 (before and after exercise)
Title
Changes in cognitive function (context memory)
Description
Assessing changes in source and context memory (m/s & number of errors) using the Gorilla Experiment Builder on a laptop. spatial anticipation
Time Frame
At baseline, week 6 and at week 12 (before and after exercise)
Title
Changes in cognitive function (spatial anticipation)
Description
Assessing changes in spatial anticipation (m/s & number of errors) using the Gorilla Experiment Builder on a laptop.
Time Frame
At baseline, week 6 and at week 12 (before and after exercise)
Title
Changes in body composition variables
Description
Assessing changes in body composition variables using the Tanita. Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in body composition variables (fat & lean mass percentage)
Description
Assessing changes in body fat mass (Body Fat mass %) and lean mass in percentage (Lean mass %) using the Tanita.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in body composition variables (fat free and muscle mass)
Description
Assessing changes in fat free mass (kg) and muscle mass (kg) using the Tanita.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in blood pressure
Description
Assessing changes in blood pressure (mmHg). Systolic and diastolic, using the ABP-Monitor Mobil-O-Graph NG
Time Frame
At baseline, week 6 and at week 12
Title
Changes in pulse wave velocity
Description
Assessing changes in pulse wave velocity (PWV) using the ABP-Monitor Mobil-O-Graph NG.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in total vascular resistance
Description
Assessing changes in total vascular resistance (TVR) using the ABP-Monitor Mobil-O-Graph NG.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in augmentation index
Description
Assessing changes in augmentation index (Alx) using the ABP-Monitor Mobil-O-Graph NG.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in augmentation pressure
Description
Assessing changes in augmentation pressure using the ABP-Monitor Mobil-O-Graph NG.
Time Frame
At baseline, week 6 and at week 12
Title
Changes in lactate
Description
Assessing changes in lactate at rest, peak, +5mins post, +10mins post, +30mins post
Time Frame
At baseline, week 6 and at week 12
Title
Changes in biomarkers for brain health
Description
Assessing changes in Brain-Derived Neurotrophic Factor (before exercise at rest and 30-mins post peak exercise)
Time Frame
At baseline, week 6 and at week 12
Title
Changes in Nitrate/Nitrite
Description
Assessing changes in plasma Nitrate and Nitrite concentrations
Time Frame
At baseline, week 6 and at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Gurney
Phone
020 3447 2800
Email
t.gurney@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Gurney
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Colllege London (ISEH)
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Gurney
Email
t.gurney@ucl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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