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Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers (TURMACTIVE)

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ClinicalTrials.gov Identifier: NCT03202901
Recruitment Status : Unknown
Verified June 2017 by Technological Centre of Nutrition and Health, Spain.
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborators:
Hospital Universitari Sant Joan de Reus
University Rovira i Virgili
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain

Brief 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

Condition or disease Intervention/treatment Phase
Knee Injuries Inflammation Knees Dietary Supplement: B-turmactive Dietary Supplement: Placebo Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 24, 2017
Estimated Primary Completion Date : November 21, 2017
Estimated Study Completion Date : March 21, 2018

Arm Intervention/treatment
Experimental: B-turmactive
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.
Dietary Supplement: B-turmactive

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


Placebo Comparator: Placebo

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)

Dietary Supplement: Placebo

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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Anthropometric data [ Time Frame: 1 week (day 1;day 7) ]

    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.


  2. Biochemistry for on-going study control [ Time Frame: 1 week (day 1;day 7) ]

    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.


  3. Inflammatory markers [ Time Frame: 1 week (day 1;day 7) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women between 30 and 65 years old.
  • Score between 15-25 out of 50 within WOMAC pain subscale
  • Signed informed consent.

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202901


Contacts
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Contact: Rosa Solà, PhD 977759300 ext 9369 rosa.sola@urv.cat
Contact: Rosa M Valls, PhD 636944723 estudis@ctns.cat

Locations
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Spain
Technological Center of Nutrition and Health (CTNS) Not yet recruiting
Reus, Spain, 43204
Contact: Francesc Puiggròs, PhD    977751382    francesc.puiggros@eurecat.org   
Sponsors and Collaborators
Technological Centre of Nutrition and Health, Spain
Hospital Universitari Sant Joan de Reus
University Rovira i Virgili
Investigators
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Study Director: Rosa M Valls, PhD Universitat Rovira i Virgili
Principal Investigator: Rosa Solà, MD, PhD Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
Study Chair: Anna Pedret, PhD Universitat Rovira i Virgili
Study Chair: Elisabet Llauradó, PhD Universitat Rovira i Virgili
Study Chair: Montse Giralt, MD, PhD Universitat Rovira i Virgili

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Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT03202901     History of Changes
Other Study ID Numbers: B-TURMACTIVE
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technological Centre of Nutrition and Health, Spain:
knee-pain, curcuma, inflammation
Additional relevant MeSH terms:
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Inflammation
Knee Injuries
Pathologic Processes
Leg Injuries
Wounds and Injuries