Sexual DysfunctionNCT05632367
Relationship Between Nutrition and Sexual Activity
An observational study of Sexual Dysfunction and Mediterranean Diet, run by Istanbul University.
Trial summary
Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. Female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Mediterranean Diet, Aphrodisiac Foods
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 31 Dec 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study was selected among adult obesity patients who were followed up and treated in the last six months of 2015 at Istanbul University Istanbul Medical Faculty Obesity Polyclinic. 185 patients aged 18 years and over were included in the study.
Who may be able to join
- Female patients with menstrual bleeding
- Sexually active male and female patients
- 18 years and older age
Who cannot join
- <18 years of age
- Female patients with menopause
- Female patients that have undergone hormone therapy in the last 12 months
- Sexually inactive male and female patients
- Patients with diabetes
- Patients with a history of psychiatric illness
Show all 9Show fewer
- Patients with cognitive impairment
- Patients with hormone-dependent tumors
- Patients taking a drug known to reduce sexual desire
About this study
Official title: The Effects of Nutritional Characteristics of Obese Men and Women on Their Sexual Functions.
Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. Female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. Although incidence and prevalence rates vary, it has been reported that women range between 30% and 50%.
Male sexual dysfunction is not a single disease. Male sexual arousal refers to the entire process of sexual activity for men, including penile erection, penile penetration, ejaculation, and any obstruction in a single connection. It is a significant psychological distress for affected men, their sexual partners, and their health-related quality of life. Sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. It is reported in the literature that 52% of men between the ages of 40-70 experience various degrees of sexual dysfunction.
Read more
Cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension, hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. Although the positive effects of adopting healthy lifestyle changes and dietary habits in reducing the risks of these diseases have been proven, few studies have evaluated the impact of these treatment approaches on sexual dysfunction.
Studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. Some small studies have also shown that lifestyle modification and weight loss interventions improve erectile dysfunction in men with significant cardiovascular risks. The same is valid for female sexual dysfunction. The Western diet and its components are indirectly associated with sexual morbidity. The Western diet has processed foods, refined carbohydrates, and high sodium and monounsaturated fat content, which have been widely linked to the development of MetS, obesity, and diabetes. These comorbidities are also risk factors for female sexual dysfunction as well.
This study aims to evaluate the relationship between the eating habits of obese and non-obese men and women and their sexual functions.
- Keywords
- SHIM, IEFF, Sexual Dysfunction, Aphrodisiac foods, Mediterranean Diet, Healthy Eating Index
- Medical subject headings
- Sexual Dysfunction, Physiological, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function in obese women [ Time Frame: through study completion, an average of 6 months]
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Measured: Based on The Female Sexual Function Index (FSFI) questionnaire
Sexual function in non-obese women [ Time Frame: through study completion, an average of 6 months]
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Measured: Based on The Female Sexual Function Index (FSFI) questionnaire
Sexual function in obese men [ Time Frame: through study completion, an average of 6 months]
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Measured: Based on International Index of Erectile Function (IIEF) questionnaire
Sexual function in non-obese men [ Time Frame: through study completion, an average of 6 months]
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Measured: Based on International Index of Erectile Function (IIEF) questionnaire
Evaluation of which nutrients the participants consume weekly [ Time Frame: through study completion, an average of 6 months]
Mediterranean Diet Assessment Scale; It is a questionnaire consisting of 14 questions, including the type of essential oil used by the patients in meals, the amount of olive oil consumed daily, fruit and vegetable portions, margarine-butter and red meat consumption, weekly consumption of wine, pulses, fish-seafood, snacks, nuts, cake, olive oil tomato sauce consumption and whether white meat is preferred more than red meat. 1 or 0 points are taken for each question asked according to the amount of consumption, and the total score is calculated. A score of 7 and above indicates that the individual has an acceptable degree of adherence to the Mediterranean diet. A score of 9 and above shows that the individual strictly follows the Mediterranean diet.
Measured: Based on Mediterranean Diet Assessment Tool
Evaluation of which nutrients the participants consume weekly [ Time Frame: through study completion, an average of 6 months]
The AHEI grades the diet, assigning a score ranging from 0 (nonadherence) to 110 (perfect adherence), based on how often eat certain healthy and unhealthy foods.
For example, someone who reports eating no daily vegetables would score a zero, while someone who ate five or more servings a day would earn a 10. For an unhealthy option, such as sugar-sweetened drinks or fruit juice, scoring is reversed: a person who eats one or more servings would score a zero, and zero servings would earn a 10.
Measured: Based on Alternative Healthy Eating Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Jun 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Calikoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632367
- Sponsor's protocol ID
- 2015/1100
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esposito K, Ciotola M, Giugliano F, De Sio M, Giugliano G, D'armiento M, Giugliano D. Mediterranean diet improves erectile function in subjects with the metabolic syndrome. Int J Impot Res. 2006 Jul-Aug;18(4):405-10. doi: 10.1038/sj.ijir.3901447. Epub 2006 Jan 5.
PubMed 16395320La J, Roberts NH, Yafi FA. Diet and Men's Sexual Health. Sex Med Rev. 2018 Jan;6(1):54-68. doi: 10.1016/j.sxmr.2017.07.004. Epub 2017 Aug 1.
PubMed 28778698Srivatsav A, Balasubramanian A, Pathak UI, Rivera-Mirabal J, Thirumavalavan N, Hotaling JM, Lipshultz LI, Pastuszak AW. Efficacy and Safety of Common Ingredients in Aphrodisiacs Used for Erectile Dysfunction: A Review. Sex Med Rev. 2020 Jul;8(3):431-442. doi: 10.1016/j.sxmr.2020.01.001. Epub 2020 Mar 2.
PubMed 32139335Cassidy A, Franz M, Rimm EB. Dietary flavonoid intake and incidence of erectile dysfunction. Am J Clin Nutr. 2016 Feb;103(2):534-41. doi: 10.3945/ajcn.115.122010. Epub 2016 Jan 13.
PubMed 26762373Mykoniatis I, Grammatikopoulou MG, Bouras E, Karampasi E, Tsionga A, Kogias A, Vakalopoulos I, Haidich AB, Chourdakis M. Sexual Dysfunction Among Young Men: Overview of Dietary Components Associated With Erectile Dysfunction. J Sex Med. 2018 Feb;15(2):176-182. doi: 10.1016/j.jsxm.2017.12.008. Epub 2018 Jan 8.
PubMed 29325831Weinberger JM, Houman J, Caron AT, Anger J. Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities. Sex Med Rev. 2019 Apr;7(2):223-250. doi: 10.1016/j.sxmr.2017.12.004. Epub 2018 Feb 3.
PubMed 29402732Towe M, La J, El-Khatib F, Roberts N, Yafi FA, Rubin R. Diet and Female Sexual Health. Sex Med Rev. 2020 Apr;8(2):256-264. doi: 10.1016/j.sxmr.2019.08.004. Epub 2019 Oct 25.
PubMed 31669123
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutritional Characteristics of Obese Men and Women on Their Sexual Functions.
- ClinicalTrials.gov ID
- NCT05632367
- Acronym / sponsor ID
- 2015/1100
- Keywords
- SHIM, IEFF, Sexual Dysfunction, Aphrodisiac foods, Mediterranean Diet, Healthy Eating Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 30 Nov 2022 (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.
Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. Female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. Although incidence and prevalence rates vary, it has been reported that women range between 30% and 50%.
Male sexual dysfunction is not a single disease. Male sexual arousal refers to the entire process of sexual activity for men, including penile erection, penile penetration, ejaculation, and any obstruction in a single connection. It is a significant psychological distress for affected men, their sexual partners, and their health-related quality of life. Sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. It is reported in the literature that 52% of men between the ages of 40-70 experience various degrees of sexual dysfunction.
Cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension, hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. Although the positive effects of adopting healthy lifestyle changes and dietary habits in reducing the risks of these diseases have been proven, few studies have evaluated the impact of these treatment approaches on sexual dysfunction.
Studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. Some small studies have also shown that lifestyle modification and weight loss interventions improve erectile dysfunction in men with significant cardiovascular risks. The same is valid for female sexual dysfunction. The Western diet and its components are indirectly associated with sexual morbidity. The Western diet has processed foods, refined carbohydrates, and high sodium and monounsaturated fat content, which have been widely linked to the development of MetS, obesity, and diabetes. These comorbidities are also risk factors for female sexual dysfunction as well.
This study aims to evaluate the relationship between the eating habits of obese and non-obese men and women and their sexual functions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study was selected among adult obesity patients who were followed up and treated in the last six months of 2015 at Istanbul University Istanbul Medical Faculty Obesity Polyclinic. 185 patients aged 18 years and over were included in the study.
Key inclusion criteria (3 listed)
- Female patients with menstrual bleeding
- Sexually active male and female patients
- 18 years and older age
Key exclusion criteria (9 listed)
- <18 years of age
- Female patients with menopause
- Female patients that have undergone hormone therapy in the last 12 months
- Sexually inactive male and female patients
- Patients with diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexual function in obese women [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on The Female Sexual Function Index (FSFI) questionnaire
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Sexual function in non-obese women [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on The Female Sexual Function Index (FSFI) questionnaire
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Sexual function in obese men [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on International Index of Erectile Function (IIEF) questionnaire
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Sexual function in non-obese men [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on International Index of Erectile Function (IIEF) questionnaire
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Evaluation of which nutrients the participants consume weekly [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on Mediterranean Diet Assessment Tool
Mediterranean Diet Assessment Scale; It is a questionnaire consisting of 14 questions, including the type of essential oil used by the patients in meals, the amount of olive oil consumed daily, fruit and vegetable portions, margarine-butter and red meat consumption, weekly consumption of wine, pulses, fish-seafood, snacks, nuts, cake, olive oil tomato sauce consumption and whether white meat is preferred more than red meat. 1 or 0 points are taken for each question asked according to the amount of consumption, and the total score is calculated. A score of 7 and above indicates that the individual has an acceptable degree of adherence to the Mediterranean diet. A score of 9 and above shows that the individual strictly follows the Mediterranean diet.
Evaluation of which nutrients the participants consume weekly [ Time Frame: through study completion, an average of 6 months]
Time frame: Based on Alternative Healthy Eating Index
The AHEI grades the diet, assigning a score ranging from 0 (nonadherence) to 110 (perfect adherence), based on how often eat certain healthy and unhealthy foods. For example, someone who reports eating no daily vegetables would score a zero, while someone who ate five or more servings a day would earn a 10. For an unhealthy option, such as sugar-sweetened drinks or fruit juice, scoring is reversed: a person who eats one or more servings would score a zero, and zero servings would earn a 10.
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 30 Nov 2022.
- Results publication: PubMed 16395320Esposito K, Ciotola M, Giugliano F, De Sio M, Giugliano G, D'armiento M, Giugliano D. Mediterranean diet improves erectile function in subjects with the metabolic syndrome. Int J Impot Res. 2006 Jul-Aug;18(4):405-10. doi: 10.1038/sj.ijir.3901447. Epub 2006 Jan 5.
- Results publication: PubMed 28778698La J, Roberts NH, Yafi FA. Diet and Men's Sexual Health. Sex Med Rev. 2018 Jan;6(1):54-68. doi: 10.1016/j.sxmr.2017.07.004. Epub 2017 Aug 1.
- Results publication: PubMed 32139335Srivatsav A, Balasubramanian A, Pathak UI, Rivera-Mirabal J, Thirumavalavan N, Hotaling JM, Lipshultz LI, Pastuszak AW. Efficacy and Safety of Common Ingredients in Aphrodisiacs Used for Erectile Dysfunction: A Review. Sex Med Rev. 2020 Jul;8(3):431-442. doi: 10.1016/j.sxmr.2020.01.001. Epub 2020 Mar 2.
- Results publication: PubMed 26762373Cassidy A, Franz M, Rimm EB. Dietary flavonoid intake and incidence of erectile dysfunction. Am J Clin Nutr. 2016 Feb;103(2):534-41. doi: 10.3945/ajcn.115.122010. Epub 2016 Jan 13.
- Results publication: PubMed 29325831Mykoniatis I, Grammatikopoulou MG, Bouras E, Karampasi E, Tsionga A, Kogias A, Vakalopoulos I, Haidich AB, Chourdakis M. Sexual Dysfunction Among Young Men: Overview of Dietary Components Associated With Erectile Dysfunction. J Sex Med. 2018 Feb;15(2):176-182. doi: 10.1016/j.jsxm.2017.12.008. Epub 2018 Jan 8.
- Results publication: PubMed 29402732Weinberger JM, Houman J, Caron AT, Anger J. Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities. Sex Med Rev. 2019 Apr;7(2):223-250. doi: 10.1016/j.sxmr.2017.12.004. Epub 2018 Feb 3.
- Results publication: PubMed 31669123Towe M, La J, El-Khatib F, Roberts N, Yafi FA, Rubin R. Diet and Female Sexual Health. Sex Med Rev. 2020 Apr;8(2):256-264. doi: 10.1016/j.sxmr.2019.08.004. Epub 2019 Oct 25.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and Mediterranean Diet, run by Istanbul University.
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 3 inclusion and 9 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Sexual function in obese women [ Time Frame: through study completion, an average of 6 months] (time frame: Based on The Female Sexual Function Index (FSFI) questionnaire). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05632367, which also lists 7 linked publications.
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 30 Nov 2022.