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

Knee Injuries Clinical Trial

— TURMACTIVE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202901
• Other study ID #: B-TURMACTIVE
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: December 19, 2017

Study information

• Verified date: February 2022
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Inflammation Knees
• Knee Injuries

Intervention

Dietary Supplement:
• 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
• 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

Locations

Country	Name	City	State
Spain	Technological Center of Nutrition and Health (CTNS)	Reus

Sponsors (3)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain	Hospital Universitari Sant Joan de Reus, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 week (day 1;day 7)
Secondary	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.	1 week (day 1;day 7)
Secondary	Inflammatory markers	C reactive protein (mg/dL), IL-1ß (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.	1 week (day 1;day 7)