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Trial record 4 of 81 for:    extract | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03703024
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Atlantia Food Clinical Trials

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: Raspberry Leaf Extract Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, randomized, placebo-controlled clinical study.
Masking: Double (Participant, Investigator)
Masking Description: Double blind model
Primary Purpose: Health Services Research
Official Title: A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Placebo
Maltodextrin
Dietary Supplement: Placebo
Delivered in a capsule
Other Name: Maltodextrin

Active Comparator: Low dose
200mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast.
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.

Active Comparator: High dose
400mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast.
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.




Primary Outcome Measures :
  1. Change, if any, in Pain Scores from baseline to the end of treatment using WOMAC [ Time Frame: 12-13 weeks ]

    Change from baseline to study completion in pain scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) To assess pain, stiffness, and physical function in patients with knee osteoarthritis

    The WOMAC consists of 24 items divided into 3 subscales:

    • Pain (5 items)
    • Stiffness (2 items)
    • Physical Function (17 items)

    The scale uses the following descriptors for all items: none, mild, moderate, severe, and extreme. These correspond to an ordinal scale of 0-4.

    The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.



Secondary Outcome Measures :
  1. Change, if any, from baseline to the end of treatment in WOMAC stiffness sub-score [ Time Frame: 12-13 weeks ]

    WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine stiffness score.

    •Stiffness (2 items): after first waking and later in the day. The score for stiffness = 0-8. A higher score indicates stiffness.


  2. Change, if any, from baseline to the end of treatment in WOMAC physical function sub-score. [ Time Frame: 12-13 weeks ]

    WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine change in physical function from baseline to study completion.

    •Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

    The possible score for Physical function ranges from 0-68. A higher score indicates bad physical function.


  3. Change, if any, from baseline to the end of treatment in WOMAC composite score [ Time Frame: 12-13 weeks ]
    The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine a composite score of the 3 subscales.

  4. Change, if any, in pain score using the VAS (for target knee joint & all other joints separately) [ Time Frame: 12-13 weeks ]
    Visual Analogue Scale (VAS) features a horizontal line with the words NO PAIN on the left and WORST PAIN on the right. The subject marks the line to indicate overall pain in the previous 6 weeks. The line is then measured in mm and a higher measurement indicates greater pain.

  5. Change in Quality of Life scores [ Time Frame: 12-13 weeks ]
    Participant Global Assessment using a short form survey of 36 questions can observe subjects overall quality of life.

  6. Change, if any, in walking speed [ Time Frame: 12-13 weeks ]
    20 m walking test is timed at each visit and will be compared to determine if there is a change in speed throughout the duration of the study.

  7. Change, if any, in physical performance [ Time Frame: 12-13 weeks ]
    Short Physical Performance Battery (SPPB) is performed at each visit and will be compared to determine if there is a change in physical performance throughout the duration of the study. The SPPB includes a balance test, gait speed test and chair stand test. All of which can indicate if there is a change from week 1 to 12.

  8. Change, if any, in activity levels [ Time Frame: 12-13 weeks ]
    International Physical Activity Questionnaire (IPAQ) will be used to determine a change in activity levels throughout the duration of the study. Expressed as MET-min per week: MET level (walking, moderate/vigorous exercise) x minutes of activity/day x days per week.

  9. Reduction in use of medication to manage pain compared to placebo [ Time Frame: 12-13 weeks ]
    A device is provided to each subject upon randomisation with instructions to complete a series of questions daily. These questions include frequency and amount of medication consumed on said day. This is monitored to observe the use of medication throughout the 12-13 week study duration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

  1. Be aged 30 to 75 years (inclusive),
  2. Be willing to provide informed consent,
  3. Have a BMI between 18.5 and 32 kg/m2,
  4. Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 12 months prior to Screening,
  5. Have radiographic evidence of OA in the tibio-femoral compartment of the target knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken no longer than 18 months,
  6. Have mild to moderate pain not adequately or completely controlled with anti-inflammatory drugs,
  7. Be able to perform the 20-meter walking test and to understand all questions from the WOMAC questionnaire.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

1. Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:

  • non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
  • child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 5. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. Has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. Sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).

    v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.

    1. Patient with secondary OA (due to a known disorder)
    2. Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken no longer than 12 months prior to Screening, and before any baseline assessment,
    3. Has clinically apparent tense effusion of the target knee or other joint,
    4. Has had viscosupplementation in any joint including the target knee or other joint within 9 months prior to Screening,
    5. Subject is taking any anti-inflammatory steroid medications, salicylates (aspirin) or Propionic acid derivatives (ibuprofen), for 2 weeks prior to study entry,
    6. Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.),
    7. Symptomatic OA of the contralateral knee that is not responsive to paracetamol and requires other therapy,
    8. Taking any calcium supplements (4-week washout) or other supplement e.g. glucosamine, chondroitin,
    9. Any medical condition deemed exclusionary by the Principal Investigator/Study doctor,
    10. Subject has a history of drug and / or alcohol abuse at the time of enrolment,
    11. Change of dietary habit within the preceding month,
    12. Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease,
    13. Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days,
    14. Subject with known allergy to components of the test product,
    15. Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements,
    16. Subject has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years,
    17. Subject has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives,
    18. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703024


Locations
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Ireland
Atlantia CRO, Heron House
Blackpool, Munster, Ireland, T23R50R
Sponsors and Collaborators
Atlantia Food Clinical Trials
Investigators
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Principal Investigator: Prof Michael Molloy Consultant Rheumatologist, Consultants Private Clinic, Cork University Hospital, Bishopstown road, Wilton, Cork.

Additional Information:
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Responsible Party: Atlantia Food Clinical Trials
ClinicalTrials.gov Identifier: NCT03703024     History of Changes
Other Study ID Numbers: AFCRO-070
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases