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

April 13, 2024 updated by: Cynthia del Rocío Márquez Beltrán

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Huelva, Spain, 21071
        • Universidad de Huelva

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:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants in the comparison group will not have intervention and will not receive strawberry supplements, they will follow their conventional treatment and their usual diet. They will be evaluated before the start of the intervention, one month and two months after the intervention.
Experimental: Strawberry intervention with Fortuna variety

This group will receive an intake of strawberries of the Fortuna variety. The participants of this group will have to eat 250 g of this strawberry variety per day for 1 month.

All participants in the intervention group will be invited to participate in focus groups once the intervention has ended, in order to learn about their experiences during it.

They will be evaluated before the start of the intervention, one month and two months after the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Change from baseline pain intensity at 1 month and 2 months.
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.
Distress menstrual
Time Frame: Change from baseline distress menstrual at 1 month and 2 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of life
Time Frame: Baseline, 1 month and 2 months.
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.
Anxiety State and Anxiety Trait
Time Frame: Baseline, 1 month and 2 months.
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.
Perceived well-being
Time Frame: Baseline, 1 month and 2 months.
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.
Sleep quality
Time Frame: Baseline, 1 month and 2 months.
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.
Changes amount of bleeding
Time Frame: Baseline, 1 month and 2 months.
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.
Changes menstrual issues
Time Frame: Baseline, 1 month and 2 months.
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.
Changes in menstrual pain management
Time Frame: Baseline, 1 month and 2 months.
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.
Changes in absenteeism and presenteeism days
Time Frame: Baseline, 1 month and 2 months.
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.
The impact on daily and academic activities
Time Frame: Baseline, 1 month and 2 months.
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.

Collaborators and Investigators

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

Sponsor

Cynthia del Rocío Márquez Beltrán

Collaborators

University of Huelva

Investigators

  • Study Director: Elia Fernández Martínez, PHD, Teacher and Researcher

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)

April 2, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFH-1123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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