InflammationNCT06561750
The Effect of Aspalathus Linearis on Muscle Soreness and Post-exercise Recovery in Young, Physically Inactive Women
A study testing Rooibos tea in people with Inflammation and Muscle Recovery, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Muscle Recovery, Muscle Soreness
- What is being tested?
- Rooibos tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Biomedical Research Institute, Hasselt University
Hasselt, Limburg, 3500
About this study
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.
Read the detailed description
On volunteers initial visit to the lab, they will be screened to assess their inclusion using the inclusion and exclusion criteria. Those who qualify for the study will be informed of the detailed procedures of the study. If they still decide to participate, they will be asked to read and sign the informed consent form. They will be asked to avoid taking NSAIDS during the course of the study. Participants will also be asked to refrain from the consumption of flavonoid-rich foods, drinks and supplements for 7 days prior to the test day. During the second visit (test day), baseline data such as body composition, anthropometrical variables, inflammatory markers (creatine kinase, TNF-α, IL-1 and IL-6), perceived muscle soreness and recover, and the quadriceps muscle functioning will be measured. The test will be done in the morning between 8:00 and 12:00 noon. To standardize the metabolic state of the participant during the testing sessions they will not be required to eat for at least two hours before testing. Moreover, participants will be required not to take caffeinated drinks and alcohol at least 12 hours before testing and not do any vigorous activities that have a rating of perceived exertion (RPE) more than (>) 12 on the Borg scale or any unusual exercise at least 24 hours before testing.
Participants will perform an 8 min warm-up of brisk walking on a treadmill (4-7 kph). They will then be subjected to the BIODEX exercise protocol. The protocol is composed of two exercise bouts (A and B), each of which comprises of 15 series of 12 maximum intermittent knee extensions conducted using the right leg on an isokinetic dynamometer with a 60 min break in between. During the 60 min break, the participants will cycle at 100 W on a bicycle ergometer (Monark) for 15 min in between bouts A and B, and then they rested in a semi-supine position for the next 45 min until bout B began. After completion of the exercise protocol, each participant will be asked to step down a total of four times from a bench 30.45 cm (1 ft.) high, alternating the leading leg between attempts to have each leg lead twice to assess the perceived muscle soreness using a 100-point visual analogue scale (VAS).
Participants will then be randomised into two (2) groups; the Aspalathus linearis group (AG) and the control group (CG). 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.
- Conditions
- Inflammation, Muscle Recovery, Muscle Soreness
- Being tested
- Rooibos tea, Control
- Keywords
- Aspalathus linearis, Rooibos
- Medical subject headings
- Inflammation, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rooibos teaOther
Participants will be subjected to 12 g of rooibos tea per 1200 ml of freshly boiled water
ControlOther
Participants will be subjected to 12 g per 1200 ml of freshly boiled water which is equivalent to 6 cups of tea
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum creatine kinase from Baseline to 72 hours
Blood samples will be collected at baseline and 72 hours
Measured: 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"
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 72 Hours
Secondary outcomes (2)
Change in swelling at the quadriceps muscle from Baseline to 72 hours
Quadriceps muscle swelling will be assessed using the thigh circumference measurement. The thigh circumference measurement will be done using the tape measure and performed to the nearest tenth of a centimeter. Two measurements within two millimeters of each other will be completed and averaged at each time point
Measured: Baseline and 72 hours
Change in quadriceps contractile muscle functioning from Baseline to 72 hours
Quadriceps contractile muscle functioning will be assessed using vertical jump test. Squat jumps will be executed with both hands clasped together firmly behind the back to minimize arm assistance for uniformity after warming up with 12 squat jumps of rising height. The participants will be told to keep their trunks as erect as they could
Measured: Baseline and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Nov 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Afrifa, Hasselt University
- Investigators
- Daniel Afrifa, Principal investigator, Hasselt University (HasseltU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561750
- Sponsor's protocol ID
- CME2022/054
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data (IPD) that will be published will be shared
Publications
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.
PubMed 24180469Marnewick 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.
PubMed 20833235Eijnde 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.
PubMed 11641371Laurent 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.
PubMed 20581704
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspalathus Linearis on Muscle Soreness and Post-exercise Recovery in Young, Physically Inactive Women
- ClinicalTrials.gov ID
- NCT06561750
- Acronym / sponsor ID
- CME2022/054
- Conditions
- Inflammation, Muscle Recovery, Muscle Soreness
- Keywords
- Aspalathus linearis, Rooibos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
On volunteers initial visit to the lab, they will be screened to assess their inclusion using the inclusion and exclusion criteria. Those who qualify for the study will be informed of the detailed procedures of the study. If they still decide to participate, they will be asked to read and sign the informed consent form. They will be asked to avoid taking NSAIDS during the course of the study. Participants will also be asked to refrain from the consumption of flavonoid-rich foods, drinks and supplements for 7 days prior to the test day. During the second visit (test day), baseline data such as body composition, anthropometrical variables, inflammatory markers (creatine kinase, TNF-α, IL-1 and IL-6), perceived muscle soreness and recover, and the quadriceps muscle functioning will be measured. The test will be done in the morning between 8:00 and 12:00 noon. To standardize the metabolic state of the participant during the testing sessions they will not be required to eat for at least two hours before testing. Moreover, participants will be required not to take caffeinated drinks and alcohol at least 12 hours before testing and not do any vigorous activities that have a rating of perceived exertion (RPE) more than (>) 12 on the Borg scale or any unusual exercise at least 24 hours before testing.
Participants will perform an 8 min warm-up of brisk walking on a treadmill (4-7 kph). They will then be subjected to the BIODEX exercise protocol. The protocol is composed of two exercise bouts (A and B), each of which comprises of 15 series of 12 maximum intermittent knee extensions conducted using the right leg on an isokinetic dynamometer with a 60 min break in between. During the 60 min break, the participants will cycle at 100 W on a bicycle ergometer (Monark) for 15 min in between bouts A and B, and then they rested in a semi-supine position for the next 45 min until bout B began. After completion of the exercise protocol, each participant will be asked to step down a total of four times from a bench 30.45 cm (1 ft.) high, alternating the leading leg between attempts to have each leg lead twice to assess the perceived muscle soreness using a 100-point visual analogue scale (VAS).
Participants will then be randomised into two (2) groups; the Aspalathus linearis group (AG) and the control group (CG). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Rooibos | Experimental | Other: Rooibos teaParticipants 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. |
| Control | Placebo comparator | Other: ControlParticipants in the control group will be asked to drink 1200 ml of water since rooibos has a very unique taste |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rooibos teaParticipants will be subjected to 12 g of rooibos tea per 1200 ml of freshly boiled water | Other | Rooibos |
| ControlParticipants will be subjected to 12 g per 1200 ml of freshly boiled water which is equivalent to 6 cups of tea | Other | Control |
Primary outcome
Change in Serum creatine kinase from Baseline to 72 hours
Time frame: Baseline and 72 hours
Blood samples will be collected at baseline and 72 hours
Change in perceived muscle soreness from Baseline to 72 hours
Time frame: Baseline and 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"
Change in perceived muscle recovery from Baseline to 72 hours
Time frame: Baseline and 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
Change in Tumor Necrosis Factor -alpha (TNF-α) from Baseline to 72 hours
Time frame: Baseline and 72 hours
Blood samples will be collected at Baseline and 72 hours
Change in interleukin-6 (IL-6) from Baseline to 72 hours
Time frame: Baseline and 72 Hours
Blood samples will be collected at Baseline and 72 hours
2 secondary outcomes
Change in swelling at the quadriceps muscle from Baseline to 72 hours
Time frame: Baseline and 72 hours
Change in quadriceps contractile muscle functioning from Baseline to 72 hours
Time frame: Baseline and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 24180469Sousa 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.
- Background: PubMed 20833235Marnewick 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.
- Background: PubMed 11641371Eijnde 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.
- Background: PubMed 20581704Laurent 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.
- Individual participant dataSharing planned: Yes. All Individual Participant Data (IPD) that will be published will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Afrifa principal investigator
Hasselt University (HasseltU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rooibos tea in people with Inflammation and Muscle Recovery, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum creatine kinase from Baseline to 72 hours (time frame: Baseline and 72 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561750, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.