NCT06561750

Brief Summary

Exercise has been found to exert beneficial effect on overall health. However, it also induces muscle damage at the same time. This then leads to muscle pain, temporary inflammation and reduced muscle function. These symptoms can persist for up to 72 hours after physical exertion and thus have a negative impact on a speedy recovery. Research has previously shown that antioxidants play an important role in muscle recovery after physical exertion. For example, antioxidants are known to have a positive effect on muscle damage and muscle soreness, and they also provide an anti-inflammatory effect. An important group of antioxidants are the flavonoids, which are abundantly present in rooibos (aspalathus linearis) tea. Previous research has shown that rooibos tea has a performance-enhancing effect during physical exertion. Despite these positive findings during physical exertion, the effect of rooibos tea on muscle recovery is not yet well known. Moreover, the effects of antioxidants during and after physical exertion have almost only been studied in men. Therefore, the current study will investigate the effects of rooibos tea on inflammation, muscle damage and muscle pain in a female population, and whether the muscle recovery capacity can ultimately be accelerated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

February 12, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

Aspalathus linearisRooibos

Outcome Measures

Primary Outcomes (5)

  • Change in Serum creatine kinase from Baseline to 72 hours

    Blood samples will be collected at baseline and 72 hours

    Baseline and 72 hours

  • Change in perceived muscle soreness from Baseline to 72 hours

    A 10 point analogue scale will be used to assess the muscle soreness. The ratings on the scale are 0 = "no soreness or pain", 2 = "mild annoying pain", 4 = "Nagging, uncomfortable troublesome pain", 6 = "Distressing, miserable pain", 8 = "Intense, dreadful pain", and 10 = "the worst possible, unbearable, excruciating pain"

    Baseline and 72 hours

  • Change in perceived muscle recovery from Baseline to 72 hours

    The perceived exercise recovery will be assessed using the Perceived recovery status (PRS) scale. The PRS scale rates recovery from exercise from 1 to 10 with 1-3 representing poor recovery and anticipating poor performance, 4-6 consisting of moderate recovery and expecting normal performance, and 7-10 representing high recovery and expecting increased performance

    Baseline and 72 hours

  • Change in Tumor Necrosis Factor -alpha (TNF-α) from Baseline to 72 hours

    Blood samples will be collected at Baseline and 72 hours

    Baseline and 72 hours

  • Change in interleukin-6 (IL-6) from Baseline to 72 hours

    Blood samples will be collected at Baseline and 72 hours

    Baseline and 72 Hours

Secondary Outcomes (2)

  • Change in swelling at the quadriceps muscle from Baseline to 72 hours

    Baseline and 72 hours

  • Change in quadriceps contractile muscle functioning from Baseline to 72 hours

    Baseline and 72 hours

Study Arms (2)

Rooibos

EXPERIMENTAL

Participants in the AG will consume the test drink (12 g per 1200 ml of pure green rooibos tea). Participants will be asked to return after 24, 48 and 72 hours of the exercise. During each visit, the baseline measurements, perceived muscle soreness and muscle recovery will be repeated.

Other: Rooibos tea

Control

PLACEBO COMPARATOR

Participants in the control group will be asked to drink 1200 ml of water since rooibos has a very unique taste

Other: Control

Interventions

Participants will be subjected to 12 g of rooibos tea per 1200 ml of freshly boiled water

Rooibos
ControlOTHER

Participants will be subjected to 12 g per 1200 ml of freshly boiled water which is equivalent to 6 cups of tea

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a woman
  • Aged between 18-30 years
  • Must not engage regularly in more than 2 organized resistance training session per week or more than 5 h physical activity per week for the previous six months.
  • Answer "NO" to the seven questions of the Physical Activity Readiness Questionnaire plus (PAR-Q+) (Appendix B).

You may not qualify if:

  • Pregnant or lactating
  • Medication or undesirable alcohol consumption (\>2 drinks per day) and smoking
  • Have any medical condition that can have a serious impact on their ability to exercise or report acute illness, chronic disease or any other medical problems during the health screening (Appendix A) session that did not necessarily exclude them from physical activity by the PAR-Q+
  • Currently using or have used vitamin and/or antioxidant supplementation for the last 2 months.
  • Has a history of clotting disorders and are currently on non-steroidal anti-inflammatory drugs or anti-coagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Research Institute, Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (4)

  • Sousa M, Teixeira VH, Soares J. Dietary strategies to recover from exercise-induced muscle damage. Int J Food Sci Nutr. 2014 Mar;65(2):151-63. doi: 10.3109/09637486.2013.849662. Epub 2013 Nov 4.

    PMID: 24180469BACKGROUND
  • Marnewick JL, Rautenbach F, Venter I, Neethling H, Blackhurst DM, Wolmarans P, Macharia M. Effects of rooibos (Aspalathus linearis) on oxidative stress and biochemical parameters in adults at risk for cardiovascular disease. J Ethnopharmacol. 2011 Jan 7;133(1):46-52. doi: 10.1016/j.jep.2010.08.061. Epub 2010 Sep 15.

    PMID: 20833235BACKGROUND
  • Eijnde BO, Van Leemputte M, Brouns F, Van Der Vusse GJ, Labarque V, Ramaekers M, Van Schuylenberg R, Verbessem P, Wijnen H, Hespel P. No effects of oral ribose supplementation on repeated maximal exercise and de novo ATP resynthesis. J Appl Physiol (1985). 2001 Nov;91(5):2275-81. doi: 10.1152/jappl.2001.91.5.2275.

    PMID: 11641371BACKGROUND
  • Laurent CM, Green JM, Bishop PA, Sjokvist J, Schumacker RE, Richardson MT, Curtner-Smith M. A practical approach to monitoring recovery: development of a perceived recovery status scale. J Strength Cond Res. 2011 Mar;25(3):620-8. doi: 10.1519/JSC.0b013e3181c69ec6.

    PMID: 20581704BACKGROUND

MeSH Terms

Conditions

InflammationMyalgia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Daniel Afrifa

    Hasselt University (HasseltU)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After undergoing a BIODEX exercise program to induce muscle soreness, participants will be randomised into 2 groups; the control and the aspalathus linearis groups. The Control group will be subjected to water while the aspalathus linearis group will be subjected to the rooibos tea
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2024

First Posted

August 20, 2024

Study Start

November 1, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All Individual Participant Data (IPD) that will be published will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After collection of data, it will be available for a maximum of 5 years
Access Criteria
Information will be shared with editors of the journal with which the data will be published. Researchers and individuals who may need the data for academic purposes may have to contact the investigator, the Biomedical Research Institute, Hasselt University for permission.
More information

Locations