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

Primary Purpose

Knee Injuries, Inflammation Knees

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

B-turmactive

Placebo

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring knee-pain, curcuma, inflammation

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Technological Center of Nutrition and Health (CTNS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

B-turmactive

Placebo

Arm 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.

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)

Outcomes

Primary Outcome Measures

Change in WOMAC pain subscale

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

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03202901

First Posted

December 12, 2016

Last Updated

March 1, 2022

Sponsor

Technological Centre of Nutrition and Health, Spain

Collaborators

Hospital Universitari Sant Joan de Reus, University Rovira i Virgili

1. Study Identification

Unique Protocol Identification Number

NCT03202901

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 19, 2017 (Actual)

Primary Completion Date

December 19, 2017 (Actual)

Study Completion Date

December 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technological Centre of Nutrition and Health, Spain

Collaborators

Hospital Universitari Sant Joan de Reus, University Rovira i Virgili

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Injuries, Inflammation Knees

Keywords

knee-pain, curcuma, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

B-turmactive

Arm Type

Experimental

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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)

Intervention Type

Dietary Supplement

Intervention Name(s)

B-turmactive

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Change in WOMAC pain subscale

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Anthropometric data

Description

Time Frame

1 week (day 1;day 7)

Title

Biochemistry for on-going study control

Description

Time Frame

1 week (day 1;day 7)

Title

Inflammatory markers

Description

Time Frame

1 week (day 1;day 7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: