Trial | NCT05013593  Report issue

Title

Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    108
The purpose of this study is to investigate the effect of red clover isoflavones in postmenopausal women with and without urge urinary incontinence and overactive bladder
Study Started
Jul 15
2019
Primary Completion
Oct 20
2021
Study Completion
Oct 20
2021
Last Update
Apr 26
2023

Dietary Supplement Red Clover Extract (RCE)

Red clover extract containing isoflavones Formononetin and biochanin A together with a heterogenous culture of probiotic lactic acid bacteria, and a natural sugar free raspberry/orange flavor. Isoflavone amount is 57.45 mg isoflavones daily (55.84 mg aglycones daily), in 70 ml red clover extract (35 ml twice daily, morning and evening together with a meal)

Other Placebo (PL)

Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.

Symptomatic RCE Experimental

Bladder symptomatic group receiving red clover extract containing the two isoflavones formononetin and biochanin A. Isoflavone amount is 57.45 mg isoflavones daily (55.84 mg aglycones daily), in 70 ml red clover extract (35 ml twice daily, morning and evening with a meal)

Healthy RCE Experimental

Healthy group without bladder symptoms receiving red clover extract containing the two isoflavones formononetin and biochanin A. Isoflavone amount is 57.45 mg isoflavones daily (55.84 mg aglycones daily), in 70 ml red clover extract (35 ml twice daily, morning and evening with a meal)

Symptomatic PL Placebo Comparator

Bladder symptomatic group receiving placebo

Healthy PL Placebo Comparator

Healthy group without bladder symptoms receiving placebo

Criteria 

Inclusion Criteria:

Postmenopausal (more than 5 years since last menstruation)
Read and understand Danish

Exclusion Criteria:

Participants receive treatment with estrogen both oral, transdermal, and topical within three months prior to inclusion in the study
Participants take estrogen-like compounds (isoflavones) three months prior to inclusion in the study
Participants take prebiotic and/or probiotic supplements within three months prior to study inclusion
Receive antibiotics (any) within three months prior to inclusion in the study
Recurrent urinary tract infections (defined as ≥ 2 infections in the last six months or ≥ 3 infections during the last year)
Acute urinary tract infection defined as positive urine culture and symptoms of acute cystitis
Previous or current diseases of the digestive and/or urinary systems evaluated by PI (including, but not limited to inflammatory bowel disease (IBD) and cancer)
Current or prior suffering from breast, ovary, and/or endometrial cancer
Use hormone spiral within the last 5 years if they are under 60 years
Hysterectomy before cessation of menstrual periods if the women are below the age of 60
No Results Posted