An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population.
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      A double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy of
      raspberry extract to alleviate symptoms of osteoarthritis in the knee.
    

Detailed description: 
      It is estimated that up to 260 subjects will be screened.

      Subjects will undergo an initial phone screen and will be asked questions regarding their
      age, weight, and general health. Eligible subjects will be scheduled for an initial visit.
      The study will involve 3 visits over a 12 to 13-week period.

      At the initial screening/baseline visit (Visit 1), the inclusion and exclusion criteria will
      be reviewed and the overall details of the study will be explained and informed consent
      obtained. Demographic data, vitals (blood pressure, heart rate and temperature),
      anthropometric measurements (weight, height and BMI) will be recorded. Family and medical
      history, and concomitant medications will be recorded. For women of child bearing age, a
      urine sample will be collected and pregnancy test performed. A blood sample (20mls) will be
      collected and haematology, biochemistry, glucose and hs-CRP will be measured. Additional
      serum will be aliquoted and stored and inflammatory biomarkers measured at a later date.

      Subjects will complete the following questionnaires: International Physical Activity
      Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert
      Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using
      a Visual Analogue Scale (VAS).

      Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete
      the 20-meter walk test.

      Subjects will be provided with an electronic tablet and instructed to complete daily and
      record daily symptoms of pain (of the target knee), compliance in relation to taking the
      study product and record any rescue or other medication taken during the study duration.

      Subjects will be randomised to one of three treatment groups as follows:

        -  Arm 1 -Placebo

        -  Arm 2 - 200mg raspberry extract

        -  Arm 3 - 400mg raspberry extract

      Subjects will be provided with a box containing 6-weeks supply of study product, along with
      an additional 4-day supply in case of loss. Subjects will be instructed to take 1 capsule
      each morning, with their breakfast, for the duration of the study.

      Subjects will return for visits at week 6 and week 12. At each visit the vitals,
      anthropometric measurements, concomitant medication and any adverse events will be recorded
      Subjects will complete the following questionnaires: International Physical Activity
      Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert
      Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using
      a Visual Analogue Scale (VAS).

      Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete
      the 20-meter walk test.

      Subjects will return their electronic device and the data will be downloaded and reviewed.

      Subjects will return any unused study product and compliance will be assessed and new study
      product administered. On Visit 3, a blood sample (20mls) will be collected and haematology,
      biochemistry, glucose and hs-CRP will be measured. Additional serum will be aliquoted and
      stored and inflammatory biomarkers measured at a later date.

      Subjects will be instructed to follow their standard diet and exercise routine and not
      consume medications that could interfere with the assessment of the study product for the
      duration of the study. Any symptoms and changes in their health status or medications will be
      recorded.
    

Intervention name(s): Raspberry Leaf Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period. One capsule to be taken every morning over a 12-13 week period.; Delivered in a capsule
Other intervention name(s): Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, randomized, placebo-controlled clinical study.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research