Knee InjuriesTURMACTIVENCT03202901
Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers
A study testing B-turmactive in people with Knee Injuries and Inflammation Knees, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Inflammation Knees
- What is being tested?
- B-turmactive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2017to 19 Dec 2017
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 30 and 65 years old.
- Score between 15-25 out of 50 within WOMAC pain subscale
- Signed informed consent.
Who cannot join
- people who take concomitant drug or supplements (multivitamins) that could interfere with the product under study.
- people who suffer froma arthritis of the knee.
- people who take more than two analgesic drugs and/or anti-inflammatory for more than three months.
- people who have a history of surgery or trauma affecting the knee.
- people with gluten sensitivity and/or allergy to gluten and sulphites (the placebo containing yeast).
- people with anemia (haemoglobin ≤ 13g/dL in men and ≤ 12g/dL in women).
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- people with BMI ≥ 30 kg / m
- women pregnant or breastfeeding.
- women with menopausal suffering from osteoporosis.
- people with liver abnormalities (ALT, AST), kidney (creatinine) or other muscular issues (creatine kinase).
- people with neurological disorders.
- people who have participated in a clinical trial or intervention study the last 30 days prior to inclusion in the study.
- people unable to follow the guidelines of the study.
- people who not signed the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers: a Pilot, Randomised, Parallel and Double Blind Pilot Trial
The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
Read the detailed description
Join pain is a common cause of consultation in primary health care in the adult population. Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic treatment, often with some secondary effects. Therefore, the research to find a natural and efficient product to reduce knee pain in a short period of time, facilitating recovery after exercise and without side effects have an interest both for industry and for the general population.
B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a) soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction with cyclodextrin. Both fractions plus vitamin C are B-turmactive.
Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy people that suffer mild or moderate knee pain and, furthermore could reduce inflammation process.
Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
- Conditions
- Knee Injuries, Inflammation Knees
- Being tested
- B-turmactive, Placebo
- Keywords
- knee-pain, curcuma, inflammation
- Medical subject headings
- Knee Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-turmactiveDietary supplement
The treatment consists of daily administration of B-TURMACTIVE®.
Treatment with B-TURMACTIVE® will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable
PlaceboDietary supplement
The treatment consists of daily administration of placebo capsule with identical format and harmless thant B-turmactive product.
Treatment with placebo will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable
| Study group | Role | What they receive |
|---|---|---|
| B-turmactive | Experimental | 1 pill of B-turmactive: 500 mg hydrosoluble fraction (free curcuminoid fraction) + 19.5 mg of lipid soluble fracion (curcuminoids enriched) + 22.5 mg vitamin C. Receives: Dietary Supplement: B-turmactive |
| Placebo | Placebo comparator | Yeast brew extract (200 mg)
Excipients:
120 mg cellulose (food additive E-460) 40 mg Compritol® E ATO (food additive E-471) 4 mg Magnesium stearate (food additive E-572) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC pain subscale
Visual analogue scale of 5 items derived from 24 items WOMAC scale
Measured: 1 week (day 1; day 3; day 7)
Secondary outcomes (3)
Anthropometric data
Trained dieticians measure weight and body composition using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Spain) and height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain), to calculate BMI: weight/height x height (kg/m2).
Waist circumference (cm) is measured midway between the lowest rib and the iliac crest using an anthropometric tape.
Measured: 1 week (day 1;day 7)
Biochemistry for on-going study control
Aspartate aminotransferase (AST) (IU/L), Alanine aminotransferase (ALT) (IU/L), Tryglycerides (mg/dL), total Cholesterol (mg/dL), High-density lipoprotein cholesterol (HDL-c) (mg/dL), Low-density lipoprotein cholesterol (LDL-c) (mg/dL) and Glucose (mg/dL).
Total cholesterol, HDL-c, Tryglicerides, AST, ALT and glucose are measured in serum by standardized enzymatic automated methods in a PENTRA-400 autoanalyzer (ABX-Horiba Diagnostics, Montpellier, France). LDL-c is calculated by the Friedewald formula.
Measured: 1 week (day 1;day 7)
Inflammatory markers
C reactive protein (mg/dL), IL-1β (ng/mL), IL-6 (ng/mL), Prostaglandin E metabolite (PGEM) (ng/mL) are measured in serum and determined by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain) or using a specific ELISA kit.
Measured: 1 week (day 1;day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start19 Sep 2017
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Responsible party
- Sponsor
- Investigators
- Rosa M Valls, PhD, Study director, University Rovira i VirgiliRosa Solà, MD, PhD, Principal investigator, Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNSAnna Pedret, PhD, Study chair, University Rovira i VirgiliElisabet Llauradó, PhD, Study chair, University Rovira i VirgiliMontse Giralt, MD, PhD, Study chair, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202901
- Sponsor's protocol ID
- B-TURMACTIVE
- Acronym
- TURMACTIVE
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers: a Pilot, Randomised, Parallel and Double Blind Pilot Trial
- ClinicalTrials.gov ID
- NCT03202901
- Acronym / sponsor ID
- TURMACTIVE / B-TURMACTIVE
- Conditions
- Knee Injuries, Inflammation Knees
- Keywords
- knee-pain, curcuma, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 29 Jun 2017 (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.
The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
Detailed description
Join pain is a common cause of consultation in primary health care in the adult population. Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic treatment, often with some secondary effects. Therefore, the research to find a natural and efficient product to reduce knee pain in a short period of time, facilitating recovery after exercise and without side effects have an interest both for industry and for the general population.
B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a) soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction with cyclodextrin. Both fractions plus vitamin C are B-turmactive.
Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy people that suffer mild or moderate knee pain and, furthermore could reduce inflammation process.
Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-turmactive | Experimental | Dietary Supplement: B-turmactive1 pill of B-turmactive: 500 mg hydrosoluble fraction (free curcuminoid fraction) + 19.5 mg of lipid soluble fracion (curcuminoids enriched) + 22.5 mg vitamin C. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboYeast brew extract (200 mg) Excipients: 120 mg cellulose (food additive E-460) 40 mg Compritol® E ATO (food additive E-471) 4 mg Magnesium stearate (food additive E-572) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 30 and 65 years old.
- Score between 15-25 out of 50 within WOMAC pain subscale
- Signed informed consent.
Key exclusion criteria (14 listed)
- people who take concomitant drug or supplements (multivitamins) that could interfere with the product under study.
- people who suffer froma arthritis of the knee.
- people who take more than two analgesic drugs and/or anti-inflammatory for more than three months.
- people who have a history of surgery or trauma affecting the knee.
- people with gluten sensitivity and/or allergy to gluten and sulphites (the placebo containing yeast).
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 |
|---|---|---|
| B-turmactiveThe treatment consists of daily administration of B-TURMACTIVE®. Treatment with B-TURMACTIVE® will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times: V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain). V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable | Dietary supplement | B-turmactive |
| PlaceboThe treatment consists of daily administration of placebo capsule with identical format and harmless thant B-turmactive product. Treatment with placebo will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times: V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain). V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable | Dietary supplement | Placebo |
Primary outcome
Change in WOMAC pain subscale
Time frame: 1 week (day 1; day 3; day 7)
Visual analogue scale of 5 items derived from 24 items WOMAC scale
3 secondary outcomes
Anthropometric data
Time frame: 1 week (day 1;day 7)
Biochemistry for on-going study control
Time frame: 1 week (day 1;day 7)
Inflammatory markers
Time frame: 1 week (day 1;day 7)
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 2 Mar 2022.
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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.
Rosa M Valls, PhD study director
University Rovira i Virgili
Rosa Solà, MD, PhD principal investigator
Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
Anna Pedret, PhD study chair
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-turmactive in people with Knee Injuries and Inflammation Knees, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
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 3 inclusion and 14 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 2 Mar 2022. 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 Spain. 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 WOMAC pain subscale (time frame: 1 week (day 1; day 3; day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.