Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25 (NUTRITION; GYN)

April 10, 2024 updated by: Armita Jamshidi, Cornell University

Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial

85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be asked the following information at the interview: name, month and year of birth, ethnicity, email, and phone number. As well, they will be prompted for their lifestyle habits, allergies, prior pregnancies and deliveries, presence of pathological disorders, medication (specifically asking about oral contraception), use of over-the-counter painkillers for period cramps/menstrual pain, expected date of next period, and menstrual cycle history. They will also be asked to complete the Menstrual Symptom Questionnaire.

The baseline questionnaire will ask the participant about their prior experience with primary dysmenorrhea symptoms and with period cramps/menstrual pain on a sliding scale.

The daily questionnaire will ask the participant to rate the extent of their period cramps/menstrual pain, to describe their pain, and whether they have taken any drugs for their period pain on that day. This questionnaire will be completed by all participants starting 2 days before their next onset of menstruation. Participants were randomly assigned Cramp Bites or the Placebo Snack: all other protocols remain the same.

After their next menstrual cycle ends, participants will be asked to fill out a final questionnaire: this questionnaire will ask the participant if they have noticed any changes in their period pain, the efficacy of the snack, and if they have suggestions/comments about the snack. This study is divided into 4 parts. Some parts will take place at Cornell University, and other parts can be completed online.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14853
        • Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.

Exclusion Criteria:

  • Pregnancy or breast feeding within 6 months
  • Primary or secondary amenorrhea
  • Body mass index less than the 1st percentile or body weight above 300 lbs
  • Undergoing menstrual suppression by medicative means
  • Unwilling to avoid painkillers (ibuprofen or naproxen) for the duration of the study unless absolutely necessary
  • Has allergies or aversions to ingredients used in either Cramp Bites or the Placebo Snack
  • Not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Granola Bites
This snack contains no known spices or nutrients that have been shown to help with spasmodic or congestive dysmenorrhea. It is the same shape and size as the active comparator.
Dietary supplement: Cramp Bites by Aunt Flo's Kitchen
Participants who are randomly assigned this snack are instructed to eat one serving each day, starting 2 days before their next onset of menstruation, and extending 3 days into their menstrual cycle. They are instructed to eat their assigned snack each time they experience menstrual cramps, whether spasmodic or congestive.
Other Names:
  • Aunt Flo's Kitchen
  • SheBalls LLC
  • Period Snack
  • Natural Period Snack
  • Armita Jamshidi
  • Period Cramp Food
  • Menstrual Cramp Food
  • Menstrual Cramp Alleviant
  • Period Pain Food
  • Menstrual Pain Food
  • Natural Period Cramp
  • Natural Menstrual Cramp
Active Comparator: Cramp Bites
This snack contains spices and ingredients that have been shown to help with both spasmodic and congestive dysmenorrhea. It is the same shape and size as the placebo comparator.
Dietary supplement: Cramp Bites by Aunt Flo's Kitchen
Participants who are randomly assigned this snack are instructed to eat one serving each day, starting 2 days before their next onset of menstruation, and extending 3 days into their menstrual cycle. They are instructed to eat their assigned snack each time they experience menstrual cramps, whether spasmodic or congestive.
Other Names:
  • Aunt Flo's Kitchen
  • SheBalls LLC
  • Period Snack
  • Natural Period Snack
  • Armita Jamshidi
  • Period Cramp Food
  • Menstrual Cramp Food
  • Menstrual Cramp Alleviant
  • Period Pain Food
  • Menstrual Pain Food
  • Natural Period Cramp
  • Natural Menstrual Cramp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for Spasmodic Cramps
Time Frame: Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.
Participants rate their spasmodic cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.
Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.
Visual Analogue Scale for Congestive Cramps
Time Frame: Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.
Participants rate their congestive cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.
Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual Symptom Questionnaire (MSQ)
Time Frame: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.
Filled out during intake exam. MSQ indicates to what extent the participant suffers from spasmodic cramps, congestive cramps, or a mixture of the two.
Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product Feedback Form
Time Frame: Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.
Participants are asked to fill out a feedback form indicating how confident they were about their assigned snack's efficacy and the taste of the snack.
Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

Laidlaw Foundation
Epperson Fund
Beck Fellowship
Dan Cane Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0145243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the privacy protection of participants, individual participant data will not be disclosed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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