Impact of Menstrual Phase on Oral Glucose Sensitivity

NCT06800690 | Completed

• 2 other identifiers: 2019001483R21DC020365
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we are determining whether the hormones associated with the phases of the menstrual cycle (menstruation \& ovulation) influence taste sensitivity to glucose. We hypothesized that women would be more sensitive to oral glucose as assessed by absolute detection threshold during ovulation than when assessed during menstruation. These phases of the cycle are associated with peak plasma estradiol levels and nadir estradiol levels. There is evidence that estrogen can increase the sensitivity of the metabolic signaling pathway of the pancreatic beta-islet cells to stimulate insulin release more readily when glucose is present by increasing sensitivity of the K-ATP channel to ATP. Since the same metabolic signaling pathway is reported to be present in taste tissue, we tested whether peak estrogen levels would enhance taste detection of glucose but not sweeteners that cannot generate ATP, such as sucralose or methyl-D-glucopyranoside (MDG).

Conditions

Ovulation; Menstruation

Keywords

estrogen; progesterone; glucose; sensitivity; taste; K-ATP

Outcome Measures

Primary Outcomes (3)

• Oral Glucose Detection Threshold

  Participants had an oral glucose detection threshold measured at menstruation (estrogen nadir) and peri-ovulation (estrogen peak). Men were tested twice two weeks apart over the same time frame as women.

  Women were tested twice over the course of a cycle at menstruation and ovulation, and this was repeated for two cycles (across two months).

• Oral Sucralose Detection Threshold

  Participants had an oral sucralose detection threshold measured at menstruation (estrogen nadir) and peri-ovulation (estrogen peak).

  Women were tested twice over the course of a cycle at menstruation and ovulation, and this was repeated for two cycles (across two months).

• Oral MDG Detection Threshold

  Participants had an oral s detect MDG (methyl-D-glucopyranoside) on threshold measured at menstruation (estrogen nadir) and peri-ovulation (estrogen peak).

  Women were tested twice over the course of a cycle at menstruation and ovulation, and this was repeated for two cycles (across two months).

Secondary Outcomes (1)

• Concentrated Glucose Solution Preference

  Women were tested twice over the course of a cycle at menstruation and ovulation, and this was repeated for two cycles (across two months).

Study Arms (2)

Cycling Women

This is a group of women who have regular menstrual cycles.

Diagnostic Test: Urinary Estrogen Level

Men

These men serve as an age-matched control who do not have high estrogen levels, as males do not have menstrual cycles.

Diagnostic Test: Urinary Estrogen Level

Interventions

Urinary Estrogen Level DIAGNOSTIC_TEST

Women had urinary estrogen metabolite levels measured daily to identify both the nadir (menstruation) and the peak (peri-ovulation) of the cycle. Men were also tested at the same time intervals, approximately two-weeks apart.

Cycling Women; Men

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants were selected from residents in the general area around New Brunswick NJ where Rutgers University is located. Women and men were recruited of all available races and ethnicities.

You may qualify if:

• regular menstrual cycle of 21-35 days

You may not qualify if:

• hormonal contraceptives or other hormonal treatments
• a history of polycystic ovarian syndrome (PCOS)
• menstrual irregularities
• pregnancy
• diabetes mellitus
• thyroid conditions
• recent COVID-19 infection
• alterations in taste or smell
• medications affecting blood pressure

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Department of Nutritional Sciences

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Paul A Breslin, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: November 3, 2021
• Primary Completion: November 12, 2024
• Study Completion: December 10, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: March 2025 - February 2032
• Access Criteria: Those requiring data for further analysis or for publication purposes at an institute of research or higher education may request information. Requests must describe the types of analyses that will be conducted.

Locations

US (1)