Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25

Phase 2

Completed

• Conditions: Menstrual Discomfort; Menstrual Pain; Cramps; Dysmenorrhea Primary; Menstrual Cycle Abnormal; Period Pain; Premenstrual Syndrome; PCOS; PCOS (Polycystic Ovary Syndrome) of Right Ovary; Period Problem
• Interventions: Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen

• Registration Number: NCT06227676
• Lead Sponsor: Cornell University

Brief Summary

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.

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 Timeline

• Study Start: 2022-07-21
• Primary Completion: 2022-09-15
• Study Completion: 2022-10-31
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cramp Bites	Cramp Bites by Aunt Flo's Kitchen	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.
Granola Bites	Cramp Bites by Aunt Flo's Kitchen	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for Spasmodic Cramps	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.
Visual Analogue Scale for Congestive Cramps	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.

Secondary Outcome Measures

Name	Time	Method
Menstrual Symptom Questionnaire (MSQ)	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.

Trial Locations

Locations (1)

Cornell University; 🇺🇸 Ithaca, New York, United States