The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress

Primary Dysmenorrhea Clinical Trial

Official title:

The Effectiveness of an Intervention Based on the Consumption of Fresh Strawberries From the Huelva Region on Menstrual Pain and Menstrual Distress in Young University Students

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06250660
• Other study ID #: PFH-1123
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University of Huelva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to know the effectiveness of an intervention based on the consumption of fresh strawberries from the Huelva region on menstrual pain and menstrual distress in young university students with primary dysmenorrhea, compared to a control group of students.

The participants with dysmenorrhea will be divided into two groups, the assignment will be random to the intervention group with strawberry intake for a month and comparing its effect with de control group. The results of the evaluations carried out prior, to the month and 2 months of the intervention will be compared.

Description:

Dysmenorrhea is a prevalent problem among women of childbearing age; previous studies carried out among young university students have identified that it affects 74% of them. Dysmenorrhea can also be accompanied by the well-known menstrual distress, which has been estimated to affect between 75 and 94% of women. The symptoms included in menstrual distress are diverse, including irritability, nausea, vomiting, abdominal pain, general weakness or fatigue, among others. Dysmenorrhea and distress have a significant impact on the lives of women who suffer from it, affecting their social life, quality of life and academic and work performance.

The methods that women use to relieve dysmenorrhea are usually pharmacological, with NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and hormonal contraceptives, but these are not free of adverse effects, so more and more studies are investigating non-pharmacological methods to relieve pain. Menstrual distress is also being included as an object of study.

A healthy lifestyle has been shown to be beneficial in relieving primary dysmenorrhoea. In particular, exercise and eating at least 2 pieces of fruit per day have been identified as protective habits.

Most of the studies that evaluate food intake in women with dysmenorrhea are observational and the few clinical trials that exist are with small samples. Strawberries are rich in flavonoids and phenolic acids, giving them anti-inflammatory and antioxidant properties. Studies carried out with strawberries have shown their benefits against chronic inflammatory and cardiovascular diseases. For these reasons, it is necessary a clinical trial to evaluate the benefits of strawberry in relieving dysmenorrhea and menstrual distress.

Carrying out a clinical trial with strawberries is a challenge. Firstly, there is no consensus on the optimal dose that should be ingested to influence health biomarkers. On the other hand, the use of fresh strawberries involves a significant cost, in addition to the fact that it is a seasonal fruit, which is why the most of trials with strawberries are carried out with freeze-dried strawberry powder.

The aim of this study is to analyze the benefits of strawberry consumption in relieving menstrual pain using the VAS (Visual Analogue Scale) scale and menstrual distress using the MEDI-Q scale, previously validated in Spanish in a previous phase of the study in female university students. The results obtained will be compared between the intervention group belonging to the intake of strawberry (specifically the "Fortuna" variety) and with a control group that will continue with their usual diet during the same period of time. They will be evaluated previously, one month and two months after receiving the intervention. The project has been approved by the Andalusian Ethics and Research Committee.

For the design of the clinical trial, previous studies on food intake and dysmenorrhea, as well as studies on the health benefits of strawberries, have been taken into account.

The "Fortuna" strawberry variety will be provided by the association Fres Huelva and must be eaten daily for a month. Participants will be provided with a menstrual diary in order to avoid forgetfulness bias. Participants who are part of the intervention group will be invited to participate in focus groups in order to know about their experiences during the trial.

Our hypothesis is that women who regularly consume strawberries in their diet will improve their pain intensity and levels of menstrual distress, as well as other symptoms associated with dysmenorrhea.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Nulliparous women

• Suffer menstrual pain at least 1 time in the last 6 months or 3 times in the last year

• Without a history of diagnosed gynecological pathology

• Not taking hormonal contraception

• Being enrolled at the University of Huelva for the academic year 2023/2024

Exclusion Criteria:

• Those who do not meet the inclusion criteria

• Being in the process of mobility during the months of study

• Have had an abortion

• Suffer from a problem that requires limiting the consumption of fruit or strawberries in their diet

• Suffer from a chronic disease that causes pain

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Pain
• Primary Dysmenorrhea

Intervention

Dietary Supplement:
• Strawberry Intervention
This is an intervention based on the intake of strawberry, specifically the "Fortuna" variety. This intervention is based on the intake of 250 g of fresh strawberries per day for a month. The amount and duration of strawberry intake has been consulted in other studies carried out with strawberries.

Locations

Country	Name	City	State
Spain	Universidad de Huelva	Huelva

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia del Rocío Márquez Beltrán	University of Huelva

Country where clinical trial is conducted

Spain, 

References & Publications (26)

Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302. — View Citation

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Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275. — View Citation

Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5. — View Citation

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Cholbeigi E, Rezaienik S, Safari N, Lissack K, Griffiths MD, Alimoradi Z. Are health promoting lifestyles associated with pain intensity and menstrual distress among Iranian adolescent girls? BMC Pediatr. 2022 Oct 5;22(1):574. doi: 10.1186/s12887-022-03639-x. — View Citation

Ezzat-Zadeh Z, Henning SM, Yang J, Woo SL, Lee RP, Huang J, Thames G, Gilbuena I, Tseng CH, Heber D, Li Z. California strawberry consumption increased the abundance of gut microorganisms related to lean body weight, health and longevity in healthy subjects. Nutr Res. 2021 Jan;85:60-70. doi: 10.1016/j.nutres.2020.12.006. Epub 2020 Dec 5. — View Citation

Fernandez-Martinez E, Abreu-Sanchez A, Perez-Corrales J, Ruiz-Castillo J, Velarde-Garcia JF, Palacios-Cena D. Living with Pain and Looking for a Safe Environment: A Qualitative Study among Nursing Students with Dysmenorrhea. Int J Environ Res Public Health. 2020 Sep 13;17(18):6670. doi: 10.3390/ijerph17186670. — View Citation

Fernandez-Martinez E, Abreu-Sanchez A, Velarde-Garcia JF, Iglesias-Lopez MT, Perez-Corrales J, Palacios-Cena D. Living with Restrictions. The Perspective of Nursing Students with Primary Dysmenorrhea. Int J Environ Res Public Health. 2020 Nov 17;17(22):8527. doi: 10.3390/ijerph17228527. — View Citation

Fernandez-Martinez E, Perez-Corrales J, Palacios-Cena D, Abreu-Sanchez A, Iglesias-Lopez MT, Carrasco-Garrido P, Velarde-Garcia JF. Pain management and coping strategies for primary dysmenorrhea: A qualitative study among female nursing students. Nurs Open. 2022 Jan;9(1):637-645. doi: 10.1002/nop2.1111. Epub 2021 Oct 30. — View Citation

Giampieri F, Alvarez-Suarez JM, Battino M. Strawberry and human health: effects beyond antioxidant activity. J Agric Food Chem. 2014 May 7;62(18):3867-76. doi: 10.1021/jf405455n. Epub 2014 Feb 3. — View Citation

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Lopez MA, Gabilondo A, Codony M, Garcia-Forero C, Vilagut G, Castellvi P, Ferrer M, Alonso J. Adaptation into Spanish of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) and preliminary validation in a student sample. Qual Life Res. 2013 Jun;22(5):1099-104. doi: 10.1007/s11136-012-0238-z. Epub 2012 Jul 27. — View Citation

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Nikkhah S, Dolatian M, Naghii MR, Zaeri F, Taheri SM. Effects of boron supplementation on the severity and duration of pain in primary dysmenorrhea. Complement Ther Clin Pract. 2015 May;21(2):79-83. doi: 10.1016/j.ctcp.2015.03.005. Epub 2015 Apr 4. — View Citation

O'Doherty AF, Jones HS, Sathyapalan T, Ingle L, Carroll S. The Effects of Acute Interval Exercise and Strawberry Intake on Postprandial Lipemia. Med Sci Sports Exerc. 2017 Nov;49(11):2315-2323. doi: 10.1249/MSS.0000000000001341. — View Citation

Parra-Fernandez ML, Onieva-Zafra MD, Abreu-Sanchez A, Ramos-Pichardo JD, Iglesias-Lopez MT, Fernandez-Martinez E. Management of Primary Dysmenorrhea among University Students in the South of Spain and Family Influence. Int J Environ Res Public Health. 2020 Aug 1;17(15):5570. doi: 10.3390/ijerph17155570. — View Citation

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Vannuccini S, Clemenza S, Cassioli E, Rossi E, Castellini G, Ricca V, Petraglia F. Uterine Fibroids, Perceived Stress, and Menstrual Distress: a Key Role of Heavy Menstrual Bleeding. Reprod Sci. 2023 May;30(5):1608-1615. doi: 10.1007/s43032-022-01126-3. Epub 2022 Dec 5. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity will be evaluated with the Visual Analog Scale (VAS). This is a self-administered, single-item measurement scale. Located on a horizontal or vertical line 10 cm (100mm) long, whose values range from 0 ("no pain") to 10 ("the worst pain imaginable"). Participants will be asked to write down the maximum perceived pain during the first 3 days of menstruation.	Change from baseline pain intensity at 1 month and 2 months.
Primary	Distress menstrual	Menstrual distress will be assessed using the MEDI-Q scale, which will be validated in Spanish in a previous phase of this study. This questionnaire evaluates symptoms in the premenstrual, menstrual and intermenstrual phases through a total of 25 items. The score ranges between 0 (absence of symptoms that cause distress during menstruation in the last year) and 125 (presence of all symptoms in more than half of menstruations in the last 12 months).	Change from baseline distress menstrual at 1 month and 2 months.
Secondary	Changes in Quality of life	To assess quality of life, EuroQol-5D (EQ-5D) will be used. It is an element for measuring HRQoL (health-related quality of life) that measures 5 dimensions of health (mobility, personal care, usual activities, pain and discomfort and, finally, anxiety and depression). In the first part, the participant must evaluate their health status through the dimensions, the second part must evaluate their health status through a visual analog scale from 0 (worst imaginable health status) to 100 (best imaginable health status).	Baseline, 1 month and 2 months.
Secondary	Anxiety State and Anxiety Trait	Anxiety will be measured through the Spanish version of the State/Trait Anxiety Inventory (STAI), made up of the Anxiety/State and Anxiety/Trait scales, with 20 items each and a Likert-type response from 0 (not at all) to 3 (very much), obtaining a total score between 0 and 60. A higher score indicates a higher level of anxiety.	Baseline, 1 month and 2 months.
Secondary	Perceived well-being	Well-being will be measured with the Spanish version of the Warwick-Edinburgh Mental Well-being Scale (EBMWE). This scale consists of 14 items, with a Likert-type response option from 1 to 5. With a total score range between 14 and 70, a higher score indicates greater mental well-being.	Baseline, 1 month and 2 months.
Secondary	Sleep quality	Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI). It is a self-report scale to assess sleep quality divided into 7 parts with 19 items, associated in 10 questions, each of which is scored between 0 (ease) and 3 (severe difficulty). The total score ranges from 0 (ease of sleeping) to 21 (difficulty in all areas).	Baseline, 1 month and 2 months.
Secondary	Changes amount of bleeding	Changes in the amount of bleeding will be measured through questions about the number of sanitary towels at day in relation to the last menstruation.	Baseline, 1 month and 2 months.
Secondary	Changes menstrual issues	Menstrual issues will be assessed through questions about days of menstruation, and length of cycle (in days) in relation to the last menstruation.	Baseline, 1 month and 2 months.
Secondary	Changes in menstrual pain management	Questions will be asked to know the method used to relieve menstrual pain; in the case of pharmacological pain relief, the dose and type of drug, and the effectiveness of the method will be asked.	Baseline, 1 month and 2 months.
Secondary	Changes in absenteeism and presenteeism days	Absenteeism and presenteeism will be consulted, through questions regarding the number of days that absenteeism or presenteeism has occurred in relation to the last menstruation.	Baseline, 1 month and 2 months.
Secondary	The impact on daily and academic activities	The impact on daily and academic activities will be evaluated with specific questions that will be answered on a scale of 0-10 (where 0 is not having a limitation and 10 is the impossibility of doing it) in relation to different situations and activities with respect to the last menstruation	Baseline, 1 month and 2 months.