NCT05632367

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 13, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

SHIMIEFFSexual DysfunctionAphrodisiac foodsMediterranean DietHealthy Eating Index

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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).

    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).

    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.

    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.

    Based on Alternative Healthy Eating Index

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Female patients with menstrual bleeding
  • Sexually active male and female patients
  • years and older age

You may not qualify if:

  • \<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
  • Patients with cognitive impairment
  • Patients with hormone-dependent tumors
  • Patients taking a drug known to reduce sexual desire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

  • La 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.

  • Srivatsav 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.

  • Cassidy 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.

  • Mykoniatis 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.

  • Weinberger 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.

  • Towe 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.

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalObesity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD; Academician; Principle Investigator

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 30, 2022

Study Start

June 1, 2015

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

November 30, 2022

Record last verified: 2022-11