Metabolic Syndrome in WomenNCT05859789
EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME
A study testing kegel exercise and Mediterranean diet regimen for 12 weeks. in people with Metabolic Syndrome in Women, run by Cairo University at 1 site in Egypt.
Trial summary
Metabolic syndrome (MS) is a cluster of metabolic abnormalities that includes hypertension, central obesity, insulin resistance, type 2-diabetes and atherogenic dyslipidaemia (1). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Metabolic Syndrome in Women
- What is being tested?
- kegel exercise and Mediterranean diet regimen for 12 weeks.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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
- Conditions
- Metabolic Syndrome in Women
- Being tested
- kegel exercise, Mediterranean diet regimen for 12 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kegel exerciseProcedure or surgery
- 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.
Mediterranean diet regimen for 12 weeks.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| control group: Kegel exercise group | Active comparator | 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. Receives: Procedure: kegel exercise |
| study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks. | Experimental | 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 Receives: Procedure: kegel exercise; Other: Mediterranean diet regimen for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female sexual function index (FSFI) questionnaire
Measured: up to 12 weeks
Sexual Quality of Life Questionnaire- Female
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome in WomenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859789
- Sponsor's protocol ID
- P.T.REC/012/004338
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF MEDITERRANEAN DIET ON SEXUAL FUNCTION IN WOMEN WITH METABOLIC SYNDROME
- ClinicalTrials.gov ID
- NCT05859789
- Acronym / sponsor ID
- P.T.REC/012/004338
- Conditions
- Metabolic Syndrome in Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: Kegel exercise group | Active comparator | Procedure: kegel exercisewill 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. |
| study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks. | Experimental | Procedure: kegel exercise, Other: 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 |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | control group: Kegel exercise group, study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks. |
| 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. | Other | study group: Kegel exercise combined with Mediterranean diet regimen for 12 weeks. |
Primary outcome
Female sexual function index (FSFI) questionnaire
Time frame: up to 12 weeks
Sexual Quality of Life Questionnaire- Female
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kegel exercise and Mediterranean diet regimen for 12 weeks. in people with Metabolic Syndrome in Women, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female sexual function index (FSFI) questionnaire (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.