The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
NCT ID: NCT05510999
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2019-06-17
2021-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Placebo
One capsule of placebo will be taken twice daily for 24 weeks.
Water soluble pollen extract fraction
The experimental product contains 180mg (360mg/day) of water soluble pollen extract fraction. Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Water soluble pollen extract fraction
Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.
Lipid soluble pollen extract fraction + water soluble pollen extract fraction
The experimental product is a combination of 9 mg lipid soluble pollen extract fraction (18mg/day) and 180 mg water soluble pollen extract fraction (360mg/day). Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Lipid soluble pollen extract fraction + water soluble pollen extract fraction
Each capsule contains a combination of 9 mg of lipid soluble pollen extract fraction and 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (18 mg/day and 360 mg/day, respectively) for 24 weeks.
Lipid soluble pollen extract fraction
The experimental product contains 9mg (18mg/day) of lipid soluble pollen extract fraction. Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Lipid soluble pollen extract fraction
Each capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks.
Water soluble pollen extract fraction + cranberry powder
The experimental product is a combination of 42 mg water soluble pollen extract fraction (84 mg/day) and 125 mg cranberry powder (250 mg/day). Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Water soluble pollen extract fraction + cranberry powder
Each capsule contains a combination of 42 mg of water soluble pollen extract and 125 mg of cranberry powder. One capsule will be taken twice daily (84 mg/day and 250 mg/day, respectively) for 24 weeks.
Interventions
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Placebo
One capsule of placebo will be taken twice daily for 24 weeks.
Water soluble pollen extract fraction
Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.
Lipid soluble pollen extract fraction + water soluble pollen extract fraction
Each capsule contains a combination of 9 mg of lipid soluble pollen extract fraction and 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (18 mg/day and 360 mg/day, respectively) for 24 weeks.
Lipid soluble pollen extract fraction
Each capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks.
Water soluble pollen extract fraction + cranberry powder
Each capsule contains a combination of 42 mg of water soluble pollen extract and 125 mg of cranberry powder. One capsule will be taken twice daily (84 mg/day and 250 mg/day, respectively) for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
2. BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive.
3. Involuntary loss of urine (incontinence) persisting for at least 1 month as determined by a score ≥ 5 on the ICIQ-SF questionnaire at the screening visit.
4. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening.
Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
* Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
* Double-barrier method
* Intrauterine devices
* Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
* Vasectomy of partner at least 6 months prior to screening
5. Agree to keep lifestyle habits consistent (dietary habits and physical activity patterns) for the duration of the trial.
6. Willing to maintain current caffeine intake. Individuals with excessive habitual caffeine intake (\>3 cups coffee or \>4 cups caffeinated tea per day or \>2 energy drinks) will be required to reduce consumption for 2 weeks prior to baseline.
7. Healthy as determined by laboratory results, medical history, and physical exam.
8. Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria
2. Allergy or sensitivity to test product ingredients.
3. Treatment (ie. pessary) or surgery (ie. sling, mesh) for urinary incontinence from a continence specialist (ie. urologist, urogynecologist, gynecologist) within the past 5 years.
4. Treatment for overactive or neurogenic bladder in previous 3 months (ie. neuromodulation, botox).
5. Initiation of pelvic floor therapy in the previous 3 months.
6. Current utilization of a catheter for urination.
7. Current urinary tract infection (UTI, confirmed by laboratory analysis), verbal confirmation of infection in previous 3 months or history of recurrent UTIs.
8. Women who are currently taking medications for urinary incontinence/overactive bladder (see Section 6.3.1).
9. Irregular menstrual periods within the previous 6 months (less than 21 or greater than 33 days between cycles).
10. Women who are within 1-year postpartum.
11. Genital malformation (i.e. Vaginal fistula) or vaginal and/or vulvar disorder (i.e. vulvovaginal atrophy).
12. Women on hormone replacement therapy (oral or topical), unless on a stable dose for ≥6 months.
13. Metal implants that may affect the DXA scan results will be assessed on case-by-case basis by the QI.
14. Current, chronic constipation reviewed on a case-by-case basis by the QI.
15. Current or history of diabetes.
16. Current or history of bladder tumour.
17. Current sexually transmitted infection (confirmed by laboratory analysis), or verbal confirmation of infection in previous 3 months.
18. Current or history of liver, kidney or heart disease.
19. Current or pre-existing unstable thyroid condition. Treatment on a stable dose of medication for over one year will be reviewed on a case-by-case basis by the QI .
20. Current or history of bleeding disorders.
21. Clinically significant abnormal laboratory results at screening.
22. Excessive consumption of alcohol equivalent to \>2 alcoholic drinks/day (average).
23. Alcohol or drug abuse within the last 6 months.
24. Individuals who are cognitively impaired and/or who are unable to give informed consent.
25. Any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive).
26. Participation in other clinical research trials one month prior to or during enrollment will be assessed case-by-case by the QI.
27. Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to provide written informed consent and complete the study or its measures, or pose significant risk to the participant.
40 Years
75 Years
FEMALE
Yes
Sponsors
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KGK Science Inc.
INDUSTRY
Graminex LLC
OTHER
Responsible Party
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Principal Investigators
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David Crowley
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
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KGK Science Inc.
London, Ontario, Canada
Countries
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Other Identifiers
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19GUHG
Identifier Type: -
Identifier Source: org_study_id
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