The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
- Conditions
- LibidoSexual Health
- Interventions
- Dietary Supplement: Placebo SupplementationDietary Supplement: GG sourced from Annatto
- Registration Number
- NCT05258513
- Lead Sponsor
- Applied Science & Performance Institute
- Brief Summary
The purpose of this study will be to examine the effectiveness of Geranylgeraniol supplementation on sexual health function in males and females following an 8-week dose escalation intervention. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their scores on the Derogatis Interview for Sexual Functioning during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into treatment or placebo conditions.
Following randomization, participants will be baseline assessed on their sexual health function using a variety of questionnaires, body composition using a whole body Dual Energy X-Ray Absorptiometry scan, blood chemistry panel, and grip strength using a hand-held dynamometer. Following baseline testing, participants will undergo 8 weeks of supplementation of their respective supplement condition. Participants will be instructed to consume two servings a day (150mg total per day) from weeks 1-4. Subject will return to the study site after 4 weeks to reassess the above-mentioned parameters. Participants will then undergo a dose escalation and be instructed to consume two servings a day (300mg total per day) from week 5-8. Sexual health questionnaires and assessments of body composition, blood chemistry, and grip strength will be conducted following the week 8 to conclude the study.
- Detailed Description
The purpose of this study will be to examine the effectiveness of Geranylgeraniol supplementation on sexual health function in males and females following an 8-week dose escalation intervention. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their scores on the Derogatis Interview for Sexual Functioning during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into treatment or placebo conditions.
Following randomization, participants will be baseline assessed on their sexual health function using a variety of questionnaires, body composition using a whole body Dual Energy X-Ray Absorptiometry scan, blood chemistry panel, and grip strength using a hand-held dynamometer. Following baseline testing, participants will undergo 8 weeks of supplementation of their respective supplement condition. Participants will be instructed to consume two servings a day (150mg total per day) from weeks 1-4. Subject will return to the study site after 4 weeks to reassess the above-mentioned parameters. Participants will then undergo a dose escalation and be instructed to consume two servings a day (300mg total per day) from week 5-8. Sexual health questionnaires and assessments of body composition, blood chemistry, and grip strength will be conducted following the week 8 to conclude the study.
Participants will be assessed for the following variables on Week 0, 4, and 8:
Primary Variables:
Subjective measures related to sexual health by administering the following questionnaire in both Males and Females
* Derogatis interview for sexual functioning self report (DISF-SR)
Subjective measures to Male specific questionnaires:
* Aging Male Symptoms (AMS)
* Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS)
* Erection Hardness Satisfaction (EHS)
* Index of Erectile Function (IIEF-5)
* Androgen Deficiency in Aging Male (ADAM) in those \>40 years old
Subjective measures to Females specific questionnaires:
* Hot flashes and night sweats
* Female Sexual Function Index
Secondary variables:
* Bone density, lean mass, and body fat percentage via Dual Energy X-Ray Absorptiometry (DEXA)
* Hand grip strength assessed via handheld dynamometer
* Bioavailable and total testosterone, estradiol, progesterone, Dihydrotestosterone (DHT), and Sex Hormone Binding Globulin (SHBG) in blood serum
Subjective measures related to well-being via the following questionnaires:
* Quality of life (SF-36)
* Perceived stress scale 10 (PSS-10)
* Sleep quality index
* Multidimensional fatigue index
* International physical activity questionnaire (IPAQ)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- Males and Females age 30-49 years old
- Males scoring 27-36 on the Aging Males Symptoms scale
- Willing to sign the Informed Consent
- English literate
- Cardiovascular, neurological, metabolic, or endocrine disease
- Drink heavily (>7 and >14 drinks per week for women and men, respectively)
- Smoke
- Renal, hematological, or hepatic disorder
- Psychiatric disorder, depression
- Peptic ulcer
- Any malignancy
- Thrombosis
- Undergone surgery that affects digestion and absorption
- Hypo- or hypertensive
- Undergoing hormone replacement therapy
- Using hormone boosting supplements (herbal or synthetic)
- Using drugs that are anti-diabetic, anti-platelet, anti-coagulant, beta blockers, or used to treat ED
- Pregnant or trying to conceive, currently breastfeeding, or have breastfeed within the prior 3 months
- Have participated in a clinical trial within the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Supplementation From weeks 1-4, participants will consume 150mg daily of a visually identical placebo. For weeks 5-8, the dose will be escalated as participants will consume 300mg daily of placebo supplementation. Geranylgeraniol Treatment GG sourced from Annatto From weeks 1-4, participants will consume 150mg daily of a Geranylgeraniol (GG). For weeks 5-8, the dose will be escalated as participants will consume 300mg daily of GG.
- Primary Outcome Measures
Name Time Method Changes in Erection Hardness Week 0, 4 and 8 Assessed by administering the Erection Hardness Score (EHS) to males for subjective measurement. Values range from 0 to 4 with higher scores demonstrating a better outcome.
Changes in Erectile Function Week 0, 4 and 8 Assessed by administering the International Index of Erectile Function (IIEF) to males for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome.
Changes in Overall Sexual Function Week 0, 4 and 8 Assessed by administering the Derogatis Interview for Sexual Functioning (DISF-SR) for subjective measurement. Values range from 0 to 8 with higher scores demonstrating a better outcome.
Changes in Aging Male Symptoms Week 0, 4, and 8 Assessed by administering the Aging Male Symptoms scale to males for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.
Changes in Androgen Deficiency in Aging Males Scale Week 0, 4, and 8 Assessed by administering the Androgen Deficiency in Aging Males scale to males for subjective measurement. Values range from 1 to 5 with higher scores demonstrating a better outcome.
Changes in Satisfaction to Treatment Week 4 and 8 Assessed by administering the Erectile Dysfunction Interview for Treatment Satisfaction (EDITS) to males for subjective measurement. Values range from 0 to 4 with lower scores demonstrating a better outcome.
Changes in Female Sexual Function Week 0, 4 and 8 Assessed by administering the Female Sexual Function Index to females for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome.
Changes in Hot Flashes Week 0, 4 and 8 Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome.
Changes in Night Sweats Week 0, 4 and 8 Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome.
- Secondary Outcome Measures
Name Time Method Sex Hormone Binding Globulin (SHBG) Week 0, 4, and 8 Experimental outcome examining total SHBG in fasted whole blood samples
Changes in Red Cell Distribution Width Week 0, 4, and 8 Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples
Testosterone Week 0, 4, and 8 Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples
Estradiol Week 0, 4, and 8 Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples
Changes in White Blood Cell count Week 0, 4, and 8 Experimental outcome examining total White Blood Cell count via fasted whole blood samples
Changes in Lymphocytes levels Week 0, 4, and 8 Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples
Changes in Granulocyte count Week 0, 4, and 8 Experimental outcome examining total Granulocyte via fasted whole blood samples
Changes in Eosinophil count Week 0, 4, and 8 Experimental outcome examining total Eosinophil via fasted whole blood samples
Changes in Basophil count Week 0, 4, and 8 Experimental outcome examining total Basophil via fasted whole blood samples
Changes in Albumin levels Week 0, 4, and 8 Experimental outcome examining total Albumin via fasted whole blood samples
Changes in Dihydrotestosterone (DHT) Week 0, 4, and 8 Experimental outcome examining total DHT in fasted whole blood samples
Changes in Red Blood Cell count Week 0, 4, and 8 Experimental outcome examining total Red Blood Cell count via fasted whole blood samples
Changes in Mean Corpuscular Volume Week 0, 4, and 8 Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples
Changes in Mean Corpuscular Hemoglobin Week 0, 4, and 8 Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples
Changes in Platelet Count Week 0, 4, and 8 Experimental outcome examining total Platelet count via fasted whole blood samples
Changes in Serum Creatinine levels Week 0, 4, and 8 Experimental outcome examining total Serum Creatinine via fasted whole blood samples
Changes in Sodium levels Week 0, 4, and 8 Experimental outcome examining total Sodium via fasted whole blood samples
Changes in Potassium levels Week 0, 4, and 8 Experimental outcome examining total Potassium via fasted whole blood samples
Changes in Total Bilirubin levels Week 0, 4, and 8 Experimental outcome examining total Bilirubin via fasted whole blood samples
Changes in Alkaline Phosphatase levels Week 0, 4, and 8 Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples
Changes in total mass Week 0, 4, and 8 Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Progesterone Week 0, 4, and 8 Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples
Changes in Hemoglobin levels Week 0, 4, and 8 Experimental outcome examining total Hemoglobin via fasted whole blood samples
Changes in Hematocrit levels Week 0, 4, and 8 Experimental outcome examining total Hematocrit via fasted whole blood samples
Changes in Mean Corpuscular Hemoglobin Concentration Week 0, 4, and 8 Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples
Changes in Granulocyte levels Week 0, 4, and 8 Experimental outcome examining percentage of Granulocytes via fasted whole blood samples
Changes in Monocyte levels Week 0, 4, and 8 Experimental outcome examining percentage of Monocytes via fasted whole blood samples
Changes in Monocyte count Week 0, 4, and 8 Experimental outcome examining total Monocytes via fasted whole blood samples
Changes in Mean Platelet Volume Week 0, 4, and 8 Experimental outcome examining total Mean Platelet volume via fasted whole blood samples
Changes in Eosinophil levels Week 0, 4, and 8 Experimental outcome examining percentage of Eosinophil via fasted whole blood samples
Changes in Basophil levels Week 0, 4, and 8 Experimental outcome examining percentage of Basophil via fasted whole blood samples
Changes in Lymphocytes count Week 0, 4, and 8 Experimental outcome examining total Lymphocytes via fasted whole blood samples
Changes in Glucose levels Week 0, 4, and 8 Experimental outcome examining total Glucose via fasted whole blood samples
Changes in Blood Urea Nitrogen levels Week 0, 4, and 8 Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples
Changes in Chloride levels Week 0, 4, and 8 Experimental outcome examining total Chloride via fasted whole blood samples
Changes in Carbon Dioxide levels Week 0, 4, and 8 Experimental outcome examining total Carbon Dioxide via fasted whole blood samples
Changes in Calcium levels Week 0, 4, and 8 Experimental outcome examining total Calcium via fasted whole blood samples
Changes in Total Protein levels Week 0, 4, and 8 Experimental outcome examining total Protein via fasted whole blood samples
Changes in Globulin levels Week 0, 4, and 8 Experimental outcome examining total Globulin via fasted whole blood samples
Changes in Alanine Transaminase levels Week 0, 4, and 8 Experimental outcome examining total Alanine Transaminase via fasted whole blood samples
Changes in Aspartate Aminotransferase levels Week 0, 4, and 8 Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples
Changes in Blood Urea Nitrogen to Creatinine ratio Week 0, 4, and 8 Experimental outcome examining the ratio of Blood Urea Nitrogen to Creatinine via fasted whole blood samples
Changes in Energy Week 0, 4, and 8 Assessed through a visual analog scale (100mm line), where 0 is no energy at all and 100 is very energized
Changes in Physical Activity Week 0, 4, and 8 Assessed by administering the International Physical Activity Questionnaire (IPAQ) for subjective measurement. Values are calculated by converting participant answers on time and intensity of physical activity to MET minutes with higher scores demonstrating a better outcome.
Changes in Albumin to Globulin ratio Week 0, 4, and 8 Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples
Changes in estimated Glomerular Filtration Rate Week 0, 4, and 8 Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples
Changes in Lean Body Mass Week 0, 4, and 8 Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Fat Mass Week 0, 4, and 8 Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Body Fat Percentage Week 0, 4, and 8 Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Body Mass Index Week 0, 4, and 8 Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Grip Strength Week 0, 4, and 8 Assessed using a handheld dynamometer
Changes in Bone Mineral Content Week 0, 4, and 8 Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Quality of Life Week 0, 4, and 8 Assessed by administering the Quality of Life Short Form (SF-36) for subjective measurement. Values range from 1 to 6 with higher scores demonstrating a better outcome.
Changes in Sleep Quality Week 0, 4, and 8 Assessed by administering the Sleep Quality Index (PSQI) for subjective measurement. Values range from 0 to 3 with lower scores demonstrating a better outcome.
Changes in Fatigue Week 0, 4, and 8 Assessed by administering the Multidimensional Fatigue Index for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.
Changes in Bone Mineral Density Week 0, 4, and 8 Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA).
Changes in Perceived Stress Week 0, 4, and 8 Assessed by administering the Perceived Stress Scale (PSS-10) for subjective measurement. Values range from 0 to 4 with lower scores demonstrating a better outcome.
Trial Locations
- Locations (1)
Applied Science and Performance Institute
🇺🇸Tampa, Florida, United States