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

NCT03202901 | Completed

• 1 other identifier: B-TURMACTIVE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Injuries; Inflammation Knees

Keywords

knee-pain, curcuma, inflammation

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC pain subscale

  Visual analogue scale of 5 items derived from 24 items WOMAC scale

  1 week (day 1; day 3; day 7)

Secondary Outcomes (3)

• Anthropometric data

  1 week (day 1;day 7)

• Biochemistry for on-going study control

  1 week (day 1;day 7)

• Inflammatory markers

  1 week (day 1;day 7)

Study Arms (2)

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.

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)

Dietary Supplement: Placebo

Interventions

B-turmactive 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

B-turmactive

Placebo 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

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 unable to follow the guidelines of the study.
• people who not signed the informed consent.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead
• Hospital Universitari Sant Joan de Reus: collaborator
• University Rovira i Virgili: collaborator

Study Sites (1)

Technological Center of Nutrition and Health (CTNS)

Reus, 43204, Spain

Location

MeSH Terms

Conditions

Knee Injuries; Inflammation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa M Valls, PhD

  University Rovira i Virgili

  STUDY DIRECTOR

• Rosa Solà, MD, PhD

  Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS

  PRINCIPAL INVESTIGATOR

• Anna Pedret, PhD

  University Rovira i Virgili

  STUDY CHAIR

• Elisabet Llauradó, PhD

  University Rovira i Virgili

  STUDY CHAIR

• Montse Giralt, MD, PhD

  University Rovira i Virgili

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: June 29, 2017
• Study Start: September 19, 2017
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

ES (1)