Clinical trial NCT05859789: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome in Women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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).
2. Their age will range (25- 35 ) years
3. 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

Eligibility criteria: Inclusion Criteria:All women will be included in this study if they fulfill the following criteria:

1. 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).
2. Their age will range (25- 35 ) years
3. 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

Primary outcomes:
measure: Female sexual function index (FSFI) questionnaire
timeFrame: up to 12 weeks
measure: Sexual Quality of Life Questionnaire- Female
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Egypt , Giza
Study officials:
References: