NCT06479993

Brief Summary

Algae, such as chlorella, are gaining popularity as a nutritious additive to whole food or as a supplement. They contain a variety of beneficial nutrients like vitamins, minerals, healthy fats, and amino acids, which can have positive effects on our health and possibly athletic performance. Chlorella, specifically, is a type of single-celled green algae that you can easily find in health stores worldwide. While there's some evidence suggesting that chlorella supplementation might improve submaximal and maximal performance for cyclists, it's unclear if it has the same impact on runners. To investigate this, the investigators aim to conduct a double-blind randomised placebo controlled study to see if taking chlorella daily for 3-weeks can enhance different aspects of running performance, both during low/moderate and intense exercise, among individuals who regularly engage in running.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 2, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

RunningVO2maxLactateOxygen Consumption

Outcome Measures

Primary Outcomes (6)

  • Changes in maximal oxygen uptake

    Changes in cardiovascular fitness variables as measured by a Cardio Pulmonary Exercise Test following the submaximal run.

    Following each 3-week supplementation period of either chlorella or placebo

  • Changes in oxygen consumption and oxygen cost

    Assessing the possible changes in oxygen consumption and oxygen cost (ml/kg/min) at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)

    Following each 3-week supplementation period of either chlorella or placebo

  • Changes in the respiratory exchange ratio

    Assessing the possible changes in the respiratory exchange ratio at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)

    Following each 3-week supplementation period of either chlorella or placebo

  • Changes in heart rate

    Assessing the possible changes in heart rate (bpm) at 60% Gas Exchange threshold (GET), 80% GET, and 75% change as measured by a metabolic cart (Vyntus)

    Following each 3-week supplementation period of either chlorella or placebo

  • Changes in lactate

    Assessing the possible changes in blood lactate at 60% Gas Exchange threshold (GET), 80% GET, and 75% change, at maximal oxygen uptake, and 15-mins post maximal as measured by the Biosen.

    Following each 3-week supplementation period of either chlorella or placebo

  • Changes in glucose

    Assessing the possible changes in blood glucose at 60% Gas Exchange threshold (GET), 80% GET, and 75% change, at maximal oxygen uptake, and 15-mins post maximal as measured by the Biosen.

    Following each 3-week supplementation period of either chlorella or placebo

Secondary Outcomes (1)

  • Changes in nutritional status

    Following each 3-week supplementation period of either chlorella or placebo

Study Arms (2)

Chlorella supplementation

EXPERIMENTAL

Supplementation of chlorella (6g/day for 3-weeks)

Dietary Supplement: Chlorella supplementation

Placebo supplementation

PLACEBO COMPARATOR

Supplementation of placebo (6g/day for 3-weeks)

Dietary Supplement: Placebo supplementation

Interventions

Chlorella supplementationDIETARY_SUPPLEMENT

Supplementation with chlorella (6g/day for 3-weeks)

Chlorella supplementation
Placebo supplementationDIETARY_SUPPLEMENT

Supplementation with placebo - microcrystalline cellulose (6g/day for 3-weeks)

Placebo supplementation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-50.
  • Run regularly (3-4 times a week).
  • Train with a purpose to compete.
  • Consider running to be your main sport.
  • Be comfortable running continuously for over 30-minutes at moderate intensity.
  • Represent a local running club.

You may not qualify if:

  • Individuals taking blood thinners.
  • Known allergies to algae/mould and iodine.
  • Any illness/conditions identified on PARQ (please see attached PARQ)
  • Taking immunosuppressant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Colllege London (ISEH)

London, W1T 7HA, United Kingdom

RECRUITING

Study Officials

  • Tom Gurney

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 2, 2024

First Posted

June 28, 2024

Study Start

January 5, 2024

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

June 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations