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OvulationNCT06800690

Impact of Menstrual Phase on Oral Glucose Sensitivity

An observational study of Ovulation and Menstruation, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 46 yearsHealthy volunteers can take part
Conditions the study is for
Ovulation, Menstruation
What is being tested?
Urinary Estrogen Level
How many people
22 participants
Where
1 siteUnited States
Study dates
3 Nov 2021to 10 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 46 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • regular menstrual cycle of 21-35 days

Who cannot join

  • hormonal contraceptives or other hormonal treatments
  • a history of polycystic ovarian syndrome (PCOS)
  • menstrual irregularities
  • pregnancy
  • diabetes mellitus
  • thyroid conditions
Show all 9Show fewer
  • recent COVID-19 infection
  • alterations in taste or smell
  • medications affecting blood pressure

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Department of Nutritional Sciences

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: Role of Metabolic Sensing in Human Sweet Taste

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).

Read the detailed description

Participants: The participants consisted of 15 healthy, non-obese, cycling females between the ages of 18-46 years. All participants completed informed consent and the study protocol was approved by the Rutgers University Institutional Review Board. 30 participants were screened for eligibility requirements. Inclusion criteria consisted of a regular menstrual cycle of 21-35 days. Exclusion criteria included 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, and medications affecting blood pressure. 23 participants were recruited and 7 participants became ineligible due to a variety of factors including: starting hormonal contraception, an irregular or missed cycle, <100 ng/mL E3G throughout periovulation, a lack of increased E3G at ovulation as compared to menstruation or lost to follow up. The participants in the control group consisted of 7 healthy, non-obese males between the ages of 18-26 years old.

Ovulation Tracking: Participants were asked to test their urine at the first urination of the day with Mira fertility MAX wands (San Francisco, CA) according to product instructions for 5 days prior to expected ovulation. Mira fertility MAX wands detect urine luteinizing hormone (LH), oestrone-3-glucuronide (E3G), and pregnanediol (PdG). E3G is a metabolite of estrone and is a marker of plasma 17-beta-estradiol. When participants' E3Gs rose above their menstruation baseline and reached > 100 ng/mL, they were asked to undergo the taste testing.

Biological males were also tested under the same conditions at comparable time differences (approximately 2 weeks apart) as a control for variation in taste testing.

Detection Threshold Testing: Participants underwent detection threshold testing with 1/8 log step serial dilutions of D-(+)-glucose (> 99.5%, Sigma-Aldrich, USA), sucralose and methyl-D-glucopyranoside (Sigma-Aldrich, USA). The participants were randomly presented with glucose or sucralose detection testing, followed by MDG detection testing. Detection threshold testing followed a 2-alternative-forced choice (2AFC) paradigm. Two medicine cups of Millipore water and dilute stimulus were presented to the participant in random order and the participant was asked which stimulus was "not water." A 4-down-1-up modified staircase method was used to obtain the oral detection threshold of the sweet stimulus. In this method, the participant is required to make the correct choice four times until the next more dilute stimulus is presented, and if the participant is wrong once, a more concentrated stimulus is presented in the next trial. Once the participant has made 5 reversals, the last 4 concentrations are averaged and defined as the detection threshold concentration for that stimulus. Participants wore nose clips throughout their testing.

Hedonic Rating Testing: Participants were trained to use the hedonic labeled magnitude scale. Participants were presented with three rows of randomized 450 mM and 900 mM glucose solutions and asked to taste and expectorate each solution and then rate their liking of the solution on a hedonic labeled magnitude scale. The solutions were presented in random order with a 30 second rinse of Millipore water in between each stimulus. Between each row there was a 2 minute break. Subjects did not wear nose clips for this part of the study.

Being tested
Urinary Estrogen Level
Keywords
estrogen, progesterone, glucose, sensitivity, taste, K-ATP
Medical subject headings
Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urinary Estrogen LevelDiagnostic 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.

Study groups in NCT06800690
Study groupRoleWhat they receive
Cycling WomenThis is a group of women who have regular menstrual cycles.
Receives: Diagnostic Test: Urinary Estrogen Level
MenThese men serve as an age-matched control who do not have high estrogen levels, as males do not have menstrual cycles.
Receives: Diagnostic Test: Urinary Estrogen Level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Oral Sucralose Detection Threshold

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

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

  3. 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).

    Measured: 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)
  1. Concentrated Glucose Solution Preference

    Participants tasted 450 and 900 mM glucose and rated liking on a labeled hedonic scale at menstruation (estrogen nadir) and peri-ovulation (estrogen peak).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start3 Nov 2021
  3. Primary completion12 Nov 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800690
Sponsor's protocol ID
2019001483
Other IDs
R21DC020365
Status last verified
Jan 2025
First submitted
17 Jan 2025
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: When published the data will be available upon request of the article contact.

Questions about this trial

What is this clinical trial studying?

An observational study of Ovulation and Menstruation, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral Glucose Detection Threshold (time frame: Women were tested twice over the course of a cycle at menstruation and ovulation, and this was repeated for two cycles (across two months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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