NCT06391957

Brief Summary

Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

April 22, 2024

Last Update Submit

June 13, 2024

Conditions

Keywords

spirulinaexercise recovery

Outcome Measures

Primary Outcomes (1)

  • Measure changes in the concentration of blood plasma inflammatory markers via immunoassay.

    Blood plasma inflammatory markers will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group. Inflammatory markers that will be assessed include: interferon γ (IFN-γ), interleukin (IL) -1β, -4, -6, -10, tumour necrosis factor α (TNF-α) via immunoassay (pg/mL).

    Measurements take place across a 6 day experimental period.

Secondary Outcomes (3)

  • Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque on a Biodex System 3 isokinetic dynamometer.

    Measurements take place across a 6 day experimental period.

  • Measure changes in muscle function of the quadriceps using knee extensor total isokinetic work on a Biodex System 3 isokinetic dynamometer.

    Measurements take place across a 6 day experimental period.

  • Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.

    Measurements take place across a 6 day experimental period.

Study Arms (2)

Spirulina supplement

EXPERIMENTAL

3g of spirulina supplement three times daily for 5 days.

Dietary Supplement: Spirulina supplementProcedure: Eccentric exercise

Placebo supplement

PLACEBO COMPARATOR

macronutrient matched placebo supplement three times daily for 5 days.

Procedure: Eccentric exerciseDietary Supplement: Placebo supplement

Interventions

Spirulina supplementDIETARY_SUPPLEMENT

Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.

Spirulina supplement

On the morning of Day 3 (where Day 1 is when participants start taking supplements), participants perform a single bout of eccentric exercise. The exercise protocol is performed on a single leg and involves 300 (10 sets of 30 repetitions separated by 120 seconds) voluntary maximal, isokinetic, eccentric contractions of the knee extensor. Exercise is performed using a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA), and contractions are performed at 60◦/s over an 80◦ range of motion.

Placebo supplementSpirulina supplement
Placebo supplementDIETARY_SUPPLEMENT

Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.

Placebo supplement

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Are available and willing to attend St Luke's Campus, Exeter
  • Age 18 - 40
  • BMI 18.5 - 30 kg/m2
  • The participant exercises / plays sport for \> 2 h/week, but doesn't do structured resistance strength training
  • Self-reported as healthy (absence of injury or disease)
  • Have no known food allergy to algae
  • Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
  • Non-smoker

You may not qualify if:

  • Are unable to attend St Luke's Campus, Exeter
  • Are out-with age range 18 - 40
  • BMI below 18.5 or above 30 kg/m2
  • The participant does not exercise
  • The participant does regular structured resistance strength training
  • Known injury or disease that might influence study outcomes
  • Have a known food allergy to algae
  • Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, United Kingdom

RECRUITING

Central Study Contacts

Benjamin Wall, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 30, 2024

Study Start

January 4, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations