Evaluering av en kombinasjon av planteekstrakter (BSL_EP028) på felles mobilitet
Pilotstudie for å evaluere effekten av forbruket av kombinasjonen av planteekstrakter (BSL_EP028) på leddmobilitet, fysisk ytelse og vitalitet
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.
For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Madrid
-
Villaviciosa de Odón, Madrid, Spania, 28670
- Universidad Europea de Madrid
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy men and women that have joint discomfort (WOMAC score >20)
Exclusion Criteria:
- Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
- Being unable to perform the physical tests required in the study.
- Have an allergy to some component of the study product.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Combination of Plant Extracts (BSL_EP028)
Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
|
Placebo komparator: Placebo
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
Tidsramme: 8 weeks
|
It is a questionnaire consisting of 24 items divided into 3 subscales:
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SF-36 Vitality score
Tidsramme: 8 weeks
|
Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality) |
8 weeks
|
|
Physical activity measurement
Tidsramme: 8 weeks
|
Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week |
8 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of Knee Pain
Tidsramme: 8 weeks
|
Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
|
Evaluation of Hip Pain
Tidsramme: 8 weeks
|
Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
|
Timed Up and Go test
Tidsramme: 8 weeks
|
This test evaluates mobility and balance by measuring the time it takes a person to get up from a chair, walk three meters, turn around, walk to the chair, and sit. |
8 weeks
|
|
30 sec Chair Stand test
Tidsramme: 8 weeks
|
This test evaluates the strength and endurance of the lower limbs by measuring the number of times a person can get up from a chair, with arms crossed at the chest, for 30 seconds. |
8 weeks
|
|
Manual Dynamometry
Tidsramme: 8 weeks
|
Evaluates the grip strength of both hands |
8 weeks
|
|
Evaluation of Muscular power and fatigue of the lower limbs
Tidsramme: 8 weeks
|
We evaluate the strength-velocity profile that the person has in the lower limbs through a linear encoder. It measures the speed of execution of a squat (extension of hips and knees) with three different loads. |
8 weeks
|
|
Goniometric study
Tidsramme: 8 weeks
|
Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension). |
8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Helios Pareja Galeano, Universidad Europea de Madrid
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C028
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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