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

NCT ID: NCT03202901

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2017-12-19

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

B-turmactive

Intervention Type: DIETARY_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

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: collaborator

Technological Centre of Nutrition and Health, Spain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosa M Valls, PhD

Role: STUDY_DIRECTOR

University Rovira i Virgili

Rosa Solà, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS

Anna Pedret, PhD

Role: STUDY_CHAIR

University Rovira i Virgili

Elisabet Llauradó, PhD

Role: STUDY_CHAIR

University Rovira i Virgili

Montse Giralt, MD, PhD

Role: STUDY_CHAIR

University Rovira i Virgili

Locations

Technological Center of Nutrition and Health (CTNS)

Reus, , Spain

Countries

Spain

Other Identifiers

B-TURMACTIVE

Identifier Type: -

Identifier Source: org_study_id