NCT03703024

An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population.

A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Atlantia Food Clinical Trials · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Raspberry Leaf Extract	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.
DIETARY_SUPPLEMENT	Placebo	Delivered in a capsule

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-10-11
• Last updated: 2019-01-10

Locations

1 site across 1 country: Ireland