[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06800833":3,"trial-entities:NCT06800833":88,"trial-summary:NCT06800833":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":67,"locations":69,"central_contacts":84,"overall_officials":85,"references":86,"see_also_links":87},"NCT06800833","IRB-25-0010","Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health","RECRUITING","2027-12-31","2026-01","2026-01-30","2025-01-23","San Diego State University","OTHER",null,"The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.",[17],"Gut Microbiome",[],"INTERVENTIONAL","PREVENTION",[22],"NA",{"count":24,"type":25},60,"ESTIMATED",[27,31],{"type":13,"name":28,"description":29,"armGroupLabels":30},"Low fat cookies","To determine the effects of low fat cookie consumption on physiological indicators of sexual, mental, skin, and gut health",[28],{"type":13,"name":32,"description":33,"armGroupLabels":34},"Mango","To determine the effects of mango consumption on physiological indicators of sexual, mental, skin, and gut health",[32],[36,40,43,47],{"measure":37,"description":38,"timeFrame":39},"Change of sexual health questionnaire scores","Change of sexual health questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.","Baseline and week 4",{"measure":41,"description":42,"timeFrame":39},"Change of depression questionnaire scores","Change of depression questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.",{"measure":44,"description":45,"timeFrame":46},"Change of skin hydration scores","Change of skin hydration scores will be determined to examine effects of mango consumption vs low-fat cookies","Baseline, 1 min post application and week 4consumption",{"measure":48,"description":49,"timeFrame":39},"Change of microbiome diversity","Change of microbiome diversity will be determined to examine effects of mango consumption vs low-fat cookies.",[],"ALL","18 Years","50 Years",true,{"inclusion":56,"exclusion":59,"raw_text":66},[57,58],"Generally healthy subjects","BMI 20-40 kg\u002Fm2",[60,61,62,63,64,65],"Smoker","Pregnant woman","Required antibiotics use","Required dietary supplement use","Required medication of metabolic disorders, mental health and sexual health","Allergy to mango or wheat","Inclusion Criteria:\n\n* Generally healthy subjects\n* BMI 20-40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Smoker\n* Pregnant woman\n* Required antibiotics use\n* Required dietary supplement use\n* Required medication of metabolic disorders, mental health and sexual health\n* Allergy to mango or wheat",[68],"ADULT",[70],{"facility":12,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"San Diego","California","92182","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Mee Young Hong","CONTACT","619-594-6825","mhong2@sdsu.edu",{"lat":82,"lon":83},32.71571,-117.16472,[],[],[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Healthy",[],{"nct_id":4,"found":54,"summary":93,"prompt_version":103},{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study, meaning participants will receive a specific intervention (mango or low-fat cookies). It plans to enroll 60 participants.","completed","Study on Mango or Low-Fat Cookie Consumption and Health","This study is looking at how eating fresh mangoes or low-fat cookies affects your gut health, and how that might be connected to your mental health (like depression), sexual health, and skin health. Researchers want to see if consuming mangoes or low-fat cookies changes scores on questionnaires about sexual health and depression, and how it impacts skin hydration. You might be able to join if you are generally healthy, between 18 and 50 years old, and have a body mass index (BMI) between 20 and 40. You cannot participate if you smoke, are pregnant, need antibiotics or dietary supplements, or take medication for metabolic, mental, or sexual health conditions. You also can't join if you're allergic to mango or wheat. The current status of this study is unclear, and it plans to enroll 60 people.","Participants will be followed for 4 weeks after starting the intervention.",135,"You would participate in assessments at the beginning of the study (Baseline) and again at week 4. Skin hydration will also be measured 1 minute after application.","Not stated in the trial record.",[32],"v2"]