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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05859789

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome in Women	Procedure: kegel exercise Other: Mediterranean diet regimen for 12 weeks.	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jan 30, 2023

Actual Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group: Kegel exercise group 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.	Procedure: kegel exercise 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.
Experimental: study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks. 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	Procedure: kegel exercise 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. Other: Mediterranean diet regimen for 12 weeks. 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.

Arm

Intervention/Treatment

Active Comparator: control group: Kegel exercise group

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.

Procedure: kegel exercise

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.

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

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

Procedure: kegel exercise

Other: Mediterranean diet regimen for 12 weeks.

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.

Outcome Measures

Primary Outcome Measures

Female sexual function index (FSFI) questionnaire [up to 12 weeks]
Sexual Quality of Life Questionnaire- Female [up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Egypt , Giza	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Magdy Ahmed, PRINCIPAL INVESTIGATOR, Cairo University

ClinicalTrials.gov Identifier:

NCT05859789

Other Study ID Numbers:

P.T.REC/012/004338

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of May 16, 2023