Clinical trial NCT03202901: Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers
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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Inflammation Knees
Keywords: knee-pain, curcuma, inflammation
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Sant Joan de Reus
name: University Rovira i Virgili
First posted: 2017-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in WOMAC pain subscale
timeFrame: 1 week (day 1; day 3; day 7)
Secondary outcomes:
measure: Anthropometric data
timeFrame: 1 week (day 1;day 7)
measure: Biochemistry for on-going study control
timeFrame: 1 week (day 1;day 7)
measure: Inflammatory markers
timeFrame: 1 week (day 1;day 7)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Center of Nutrition and Health (CTNS)
Study officials:
affiliation: University Rovira i Virgili
name: Rosa M Valls, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
name: Rosa Solà, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili
name: Anna Pedret, PhD
role: STUDY_CHAIR
affiliation: University Rovira i Virgili
name: Elisabet Llauradó, PhD
role: STUDY_CHAIR
affiliation: University Rovira i Virgili
name: Montse Giralt, MD, PhD
role: STUDY_CHAIR
References: