Female Urogenital Nutrition- Health Study

NCT05015400 | Completed

• 1 other identifier: STUDY00014289
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess nutrition and urinary tract bacterial activity during menstruation of approximately 15 female university Reserve Officer Training Corps (ROTC) cadets and Phoenix area police officers, firefighters, and military veterans.

Conditions

Bacterial Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Uropathogenic Bacterial Activity

  Number of bacterial colonies and uropathogens found

  Change from Baseline Uropathogenic Bacterial Activity at 1 month

Secondary Outcomes (1)

• Hydration Status

  Change from Baseline Hydration Status at 1 month

Study Arms (2)

Fluid Increase

EXPERIMENTAL

The increased fluid intervention arm will begin on day 2 after the onset of bleeding (day 1) of their phase 1 menses through day 5. For the increased fluid intake intervention, participants will a) consume an additional 64 oz (1.89 L) of plain water only on top of habitual fluid intake and b) aim to at least urinate 5 times per day.

Other: Plain Water

Fluid Habitual

NO INTERVENTION

The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.

Interventions

Plain Water OTHER

To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).

Fluid Increase

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years of age or older (premenopausal)
• Have a 21-35-day menstrual cycle
• No changes in hormonal contraceptives within the last three months
• No current UTI symptoms
• Sexual activity and inactivity

You may not qualify if:

• Males
• Under 18 years of age or over 34 years of age
• Pregnant or nursing
• Menstrual irregularities effecting having a menstrual cycle to be between 21-35 days
• Progesterone-only contraceptive use (combined estrogen-progesterone and non-hormonal IUDs are okay)
• Currently taking antibiotics
• On hormone replacement therapy
• Currently experiencing symptomatic vulvovaginitis
• Diagnosed with recurrent UTI
• Not volunteering to participate

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Study Officials

• Kaila A Vento, PhD(c)

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 20, 2021
• Study Start: September 5, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 1, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.

Locations

US (1)