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EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME

Primary Purpose

Metabolic Syndrome in Women

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kegel exercise
Mediterranean diet regimen for 12 weeks.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome in Women

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:All women will be included in this study if they fulfill the following criteria: Sexually active women diagnosed with metabolic syndrome and complaining of sexual dysfunction: Abdominal adiposity (waist circumference is >88 cm) Low serum high density lipoprotein cholesterol Hypertriglyceridemia (elevated triglyceride of >150 mg/dl) Elevated blood pressure >130/85mmHg Abnormal glucose homeostasis (fasting plasma glucose concentration is >110mg/dl). Their age will range (25- 35 ) years Body mass index (BMI) ≥ (25-30) kg/m2. - Exclusion Criteria: Women who had met one of the following criteria will be excluded from the study: Women has cardiovascular disease Psychiatric problems History of alcohol abuse Smoker women Taking medication

Sites / Locations

  • Egypt , Giza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group: Kegel exercise group

study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks.

Arm Description

will receive Kegel exercise (3 sessions /week for 12 weeks)- Each female will be asked to "Try to squeeze her pelvic floor muscles as much as possible". She was instructed that the numbers she saw at the top of screen indicated the activity of the muscle (electrical activity), in microvolt (mv). The therapeutic session will be repeated 3 sessions /week for 12 weeks for each female in both groups (A&B). Each female will be instructed to Tighten her pelvic floor muscles. Hold tight and count 3 to 5 seconds, relax the muscles and count 3 to 5 seconds, then repeat 10 times, 3 times a day at least three sets of 10 to 15 repetitions a day as a home program They will be instructed not to use abdomen, thighs or buttock muscles during the contraction, avoid holding breath. Instead, breathe freely during the exercises.

kegel and Mediterranean diet regimen :kegel ex same as controlled group in addition toMediterranean diet. The recommended composition of the dietary regimen was the following: carbohydrates 50-60%, proteins 15-20%, total fat o30%, saturated fat 10% and less than 300 mg of cholesterol consumed per day. Moreover, subjects Will

Outcomes

Primary Outcome Measures

Female sexual function index (FSFI) questionnaire
Sexual Quality of Life Questionnaire- Female

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
May 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05859789
Brief Title
EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME
Official Title
EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Metabolic syndrome (MS) is a cluster of metabolic abnormalities that includes hypertension, central obesity, insulin resistance, type 2-diabetes and atherogenic dyslipidaemia (1). A woman's sexual health is associated with several psychological and interpersonal factors, and may be affected by aging and metabolic changes (2). Obesity, hypertension, dyslipidemia, and type 2-diabetes which are conditions frequently present in women with metabolic syndrome are considered risk factors for atherosclerosis and endothelial dysfunction which impairs tissue oxygenation and causes subsequent functional and structural damage to the female genital tract. A decrease in pelvic blood flow secondary to atherosclerotic disease leads to fibrosis of the vaginal wall and clitoral smooth muscle, eventually resulting in vaginal dryness and dyspareunia (3). Women with metabolic syndrome showed higher prevalence of sexual inactivity and low sexual desire, orgasm, satisfaction, and Female sexual function (FSFI) total score in respect to women without metabolic syndrome (4). There is a link between diet and sexual performance markers to get and maintain lubrication, orgasm, and frequency of sex, as food has a favourable or negative impact on sexual activity for both sexes at any age (5). The Mediterranean diet (Med Diet) is one of the most widely described and evaluated dietary patterns in scientific literature. It is based on the traditional foods that people used to eat in countries bordering the Mediterranean Sea, including France, Spain, Greece, and Italy. It is characterized by high intakes of vegetables, legumes, fruits, nuts, grains, fish, seafood, extra virgin olive oil, and a moderate intake of red wine (6). Previous studies proved that Kegel exercise raise the level of sexual satisfaction, as the pelvic floor muscle (PFM) specifically the pubococcygeus and iliococcygeus muscles are responsible for the rhythmic involuntary contractions during orgasm (7). According to the authors' knowledge, no prior research studied the effect of Mediterranean diet on sexual function in women with metabolic syndrome.
Detailed Description
200 patients with metabolic syndrome complaining of sexual dysfunction, aged 25-40 years, were randomized into two equal groups, the control group (A) received sessions of Kegel exercise three times per week for 12 weeks, the study group (B) received Kegel exercise combined with Mediterranean diet regimen for 12 weeks. Female sexual function index (FSFI) questionnaire was used to evaluate sexual function of each woman in both groups, while sexual quality of life-female (SQOL_F) questionnaire was used to assess quality of life (QoL) of each woman in both groups before and after treatment. All women will be included in this study if they fulfill the following criteria: Sexually active women diagnosed with metabolic syndrome and complaining of sexual dysfunction: Abdominal adiposity (waist circumference is >88 cm) Low serum high density lipoprotein cholesterol Hypertriglyceridemia (elevated triglyceride of >150 mg/dl) Elevated blood pressure >130/85mmHg Abnormal glucose homeostasis (fasting plasma glucose concentration is >110mg/dl). Their age will range (25- 35 ) years Body mass index (BMI) ≥ (25-30) kg/m2. Women who had met one of the following criteria will be excluded from the study: Women has cardiovascular disease Psychiatric problems History of alcohol abuse Smoker women Taking medication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome in Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group: Kegel exercise group
Arm Type
Active Comparator
Arm Description
will receive Kegel exercise (3 sessions /week for 12 weeks)- Each female will be asked to "Try to squeeze her pelvic floor muscles as much as possible". She was instructed that the numbers she saw at the top of screen indicated the activity of the muscle (electrical activity), in microvolt (mv). The therapeutic session will be repeated 3 sessions /week for 12 weeks for each female in both groups (A&B). Each female will be instructed to Tighten her pelvic floor muscles. Hold tight and count 3 to 5 seconds, relax the muscles and count 3 to 5 seconds, then repeat 10 times, 3 times a day at least three sets of 10 to 15 repetitions a day as a home program They will be instructed not to use abdomen, thighs or buttock muscles during the contraction, avoid holding breath. Instead, breathe freely during the exercises.
Arm Title
study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks.
Arm Type
Experimental
Arm Description
kegel and Mediterranean diet regimen :kegel ex same as controlled group in addition toMediterranean diet. The recommended composition of the dietary regimen was the following: carbohydrates 50-60%, proteins 15-20%, total fat o30%, saturated fat 10% and less than 300 mg of cholesterol consumed per day. Moreover, subjects Will
Intervention Type
Procedure
Intervention Name(s)
kegel exercise
Intervention Description
Each female will be asked to "Try to squeeze her pelvic floor muscles as much as possible". She was instructed that the numbers she saw at the top of screen indicated the activity of the muscle (electrical activity), in microvolt (mv). The therapeutic session will be repeated 3 sessions /week for 12 weeks for each female in both groups (A&B). Each female will be instructed to Tighten her pelvic floor muscles. Hold tight and count 3 to 5 seconds, relax the muscles and count 3 to 5 seconds, then repeat 10 times, 3 times a day at least three sets of 10 to 15 repetitions a day as a home program They will be instructed not to use abdomen, thighs or buttock muscles during the contraction, avoid holding breath. Instead, breathe freely during the exercises.
Intervention Type
Other
Intervention Name(s)
Mediterranean diet regimen for 12 weeks.
Intervention Description
kegel ex in addition to mediterrian diet . The recommended composition of the dietary regimen was the following: carbohydrates 50-60%, proteins 15-20%, total fat o30%, saturated fat 10% and less than 300 mg of cholesterol consumed per day. Moreover, subjects Will be advised to consume at least 250-300 g of fruits, 125-150 g of vegetables and 25-50 g of nuts per day.
Primary Outcome Measure Information:
Title
Female sexual function index (FSFI) questionnaire
Time Frame
up to 12 weeks
Title
Sexual Quality of Life Questionnaire- Female
Time Frame
up to 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:All women will be included in this study if they fulfill the following criteria: Sexually active women diagnosed with metabolic syndrome and complaining of sexual dysfunction: Abdominal adiposity (waist circumference is >88 cm) Low serum high density lipoprotein cholesterol Hypertriglyceridemia (elevated triglyceride of >150 mg/dl) Elevated blood pressure >130/85mmHg Abnormal glucose homeostasis (fasting plasma glucose concentration is >110mg/dl). Their age will range (25- 35 ) years Body mass index (BMI) ≥ (25-30) kg/m2. - Exclusion Criteria: Women who had met one of the following criteria will be excluded from the study: Women has cardiovascular disease Psychiatric problems History of alcohol abuse Smoker women Taking medication
Facility Information:
Facility Name
Egypt , Giza
City
Giza
Country
Egypt

12. IPD Sharing Statement

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EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME

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