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

N/ACompletedNCT03202901

Technological Centre of Nutrition and Health, Spain70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Knee Injuries Inflammation Knees

Interventions

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Technological Center of Nutrition and Health (CTNS)

Reus, Spain

Outcomes

Primary Outcomes

Change in WOMAC pain subscale

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

Time frame: 1 week (day 1; day 3; day 7)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 week (day 1;day 7)

Data from ClinicalTrials.gov

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