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

Technological Centre of Nutrition and Health, Spain

Status: Completed

Conditions: Knee Injuries; Inflammation Knees

Treatments: Dietary Supplement: Placebo; Dietary Supplement: B-turmactive

Study type: Interventional

Funder types: Other

Identifiers

NCT03202901

B-TURMACTIVE

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

B-turmactive

Experimental group

Description:

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.

Treatment:

Dietary Supplement: B-turmactive

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo