Spirulina Supplementation In Recovery From Damaging Exercise (SPIRAL)

April 29, 2024 updated by: University of Exeter
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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spirulina supplement
3g of spirulina supplement three times daily for 5 days.
Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.
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 Comparator: Placebo supplement
macronutrient matched placebo supplement three times daily for 5 days.
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.
Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure changes in the concentration of blood plasma inflammatory markers via immunoassay.
Time Frame: Measurements take place across a 6 day experimental period.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque and total isokinetic work on a Biodex System 3 isokinetic dynamometer.
Time Frame: Measurements take place across a 6 day experimental period.

Muscle function of the quadriceps 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 to report recovery of muscle function. Muscle function testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US). Muscle function measurements will include:

  • knee extensor peak isometric torque (three maximal isometric contractions at 75◦ of knee flexion)
  • knee extensor total isokinetic work (area under the torque-time curve after 30 maximal, concentric, isokinetic knee extensor contractions performed at 75◦/s through an 80◦ range of motion)
Measurements take place across a 6 day experimental period.
Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.
Time Frame: Measurements take place across a 6 day experimental period.
Perceived lower body muscle soreness 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 to report recovery of muscle. Participants will stand from a seated position and rate the corresponding sensation of lower body muscle soreness on a 100-mm visual analogue scale anchored by 'no pain' at 0 mm and 'worst possible pain' at 100 mm.
Measurements take place across a 6 day experimental period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 4530276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spirulina Supplementation in Recovery From Exercise

Clinical Trials on Spirulina supplement

3
Subscribe