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

NCT06227676 | Completed Phase 2 DMC

• 1 other identifier: IRB0145243
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea Primary; Dysmenorrhea; Menstrual Discomfort; Menstrual Problem; Menstrual Cycle Abnormal; Menstrual Pain; Period Pain; Period Problem; PMS; Premenstrual Syndrome; PCOS; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; PCOS (Polycystic Ovary Syndrome) of Left Ovary; PCOS (Polycystic Ovary Syndrome) of Right Ovary; Polycystic Ovary Syndrome; Premenstrual Dysphoric Disorder; Cramps; Ovarian Cysts

Keywords

Dysmenorrhea; Primary Dysmenorrhea; Menstrual Discomfort; Menstrual Pain; Menstrual Problem; Menstrual Cycle Abnormal; Period Pain; Period Problem; PMS; Premenstrual Syndrome; PCOS; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; PCOS (Polycystic Ovary Syndrome) of Left Ovary; PCOS (Polycystic Ovary Syndrome) of Right Ovary; Polycystic Ovary Syndrome; Premenstrual Dysphoric Disorder; Cramps; Ovarian Cysts

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale for Spasmodic Cramps

  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

  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 Outcomes (1)

• Menstrual Symptom Questionnaire (MSQ)

  Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.

Other Outcomes (1)

• Product Feedback Form

  Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.

Study Arms (2)

Granola Bites

PLACEBO COMPARATOR

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

Cramp Bites

ACTIVE COMPARATOR

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

Interventions

Cramp Bites by Aunt Flo's Kitchen DIETARY_SUPPLEMENT

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.

Also known as: 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

Cramp Bites; Granola Bites

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Participants must be assigned female at birth to be eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• Laidlaw Foundation: collaborator
• Epperson Fund: collaborator
• Beck Fellowship: collaborator
• Dan Cane Fund: collaborator

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (10)

• Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.

  PMID: 26346058 BACKGROUND

• Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.

  PMID: 33030880 BACKGROUND

• Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.

  PMID: 35320895 BACKGROUND

• Chen CX, Kwekkeboom KL, Ward SE. Self-report pain and symptom measures for primary dysmenorrhoea: a critical review. Eur J Pain. 2015 Mar;19(3):377-91. doi: 10.1002/ejp.556.

  PMID: 25059384 BACKGROUND

• Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.

  PMID: 1238078 BACKGROUND

• Guimaraes I, Povoa AM. Primary Dysmenorrhea: Assessment and Treatment. Rev Bras Ginecol Obstet. 2020 Aug;42(8):501-507. doi: 10.1055/s-0040-1712131. Epub 2020 Jun 19.

  PMID: 32559803 BACKGROUND

• Direkvand-Moghadam A, Khosravi A. The impact of a novel herbal Shirazi Thymus Vulgaris on primary dysmenorrhea in comparison to the classical chemical Ibuprofen. J Res Med Sci. 2012 Jul;17(7):668-70.

  PMID: 23798928 BACKGROUND

• Mates L, Popa DS, Rusu ME, Fizesan I, Leucuta D. Walnut Intake Interventions Targeting Biomarkers of Metabolic Syndrome and Inflammation in Middle-Aged and Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Antioxidants (Basel). 2022 Jul 21;11(7):1412. doi: 10.3390/antiox11071412.

  PMID: 35883903 BACKGROUND

• Gutman G, Nunez AT, Fisher M. Dysmenorrhea in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101186. doi: 10.1016/j.cppeds.2022.101186. Epub 2022 May 4.

  PMID: 35523674 BACKGROUND

• Negriff S, Dorn LD, Hillman JB, Huang B. The measurement of menstrual symptoms: factor structure of the menstrual symptom questionnaire in adolescent girls. J Health Psychol. 2009 Oct;14(7):899-908. doi: 10.1177/1359105309340995.

  PMID: 19786516 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Menstruation Disturbances; Premenstrual Syndrome; Polycystic Ovary Syndrome; Premenstrual Dysphoric Disorder; Muscle Cramp; Ovarian Cysts

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Women's Health Student

Model Details: Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 29, 2024
• Study Start: July 21, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 31, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)