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NCT Number: NCT03202901

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

The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain

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Key information

Conditions

Knee Injuries Inflammation Inflammation Knees Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technological Center of Nutrition and Health (CTNS)

Reus, 43204, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Collaborators

  • Hospital Universitari Sant Joan de Reus
  • University Rovira i Virgili

Registry information

Official study 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

Acronym: TURMACTIVE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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