Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250660
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-01-26
Brief Title:
The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress
Sponsor:
Cynthia del Rocío Márquez Beltrán
Organization:
University of Huelva
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None