Clinical trial NCT06250660: The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Menstrual Pain
Menstrual Distress \(Dysmenorrhea\)
Keywords: strawberry
primary dysmenorrhea
menstrual distress
pelvic pain
menstruation disturbance
Lead sponsor: University of Huelva
Sponsor class: OTHER
Collaborators: name: University of Huelva
First posted: 2024-02-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women who meet the inclusion criteria will be divided into two groups. There will be an intervention group, corresponding to the intake of strawberry and a control group. Participants will be randomly assigned to each group, the randomization will be 1:1, so there will be the same number of participants in each of the two groups. The intervention group will receive the corresponding amount of strawberries and the control group will continue with their usual diet and treatment for dysmenorrhea.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline pain intensity at 1 month and 2 months.
measure: Distress menstrual
timeFrame: Change from baseline distress menstrual at 1 month and 2 months.
Secondary outcomes:
measure: Changes in Quality of life
timeFrame: Baseline, 1 month and 2 months.
measure: Anxiety State and Anxiety Trait
timeFrame: Baseline, 1 month and 2 months.
measure: Perceived well-being
timeFrame: Baseline, 1 month and 2 months.
measure: Sleep quality
timeFrame: Baseline, 1 month and 2 months.
measure: Changes amount of bleeding
timeFrame: Baseline, 1 month and 2 months.
measure: Changes menstrual issues
timeFrame: Baseline, 1 month and 2 months.
measure: Changes in menstrual pain management
timeFrame: Baseline, 1 month and 2 months.
measure: Changes in absenteeism and presenteeism days
timeFrame: Baseline, 1 month and 2 months.
measure: The impact on daily and academic activities
timeFrame: Baseline, 1 month and 2 months.
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Universidad de Huelva
Study officials:
affiliation: Teacher and Researcher
name: Elia Fernández Martínez, PHD
role: STUDY_DIRECTOR
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