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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
83
8 weeks of placebo supplementation
8-weeks of Geranylgeraniol supplementation
Applied Science and Performance Institute
Tampa, Florida, United States
Changes in Overall Sexual Function
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.
Time frame: Week 0, 4 and 8
Changes in Aging Male Symptoms
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.
Time frame: Week 0, 4, and 8
Changes in Androgen Deficiency in Aging Males Scale
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.
Time frame: Week 0, 4, and 8
Changes in Satisfaction to Treatment
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.
Time frame: Week 4 and 8
Changes in Erection Hardness
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.
Time frame: Week 0, 4 and 8
Changes in Erectile Function
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.
Time frame: Week 0, 4 and 8
Changes in Female Sexual Function
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.
Time frame: Week 0, 4 and 8
Changes in Hot Flashes
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.
Time frame: Week 0, 4 and 8
Changes in Night Sweats
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.
Time frame: Week 0, 4 and 8
Testosterone
Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples
Time frame: Week 0, 4, and 8
Estradiol
Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples
Time frame: Week 0, 4, and 8
Progesterone
Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples
Time frame: Week 0, 4, and 8
Sex Hormone Binding Globulin (SHBG)
Experimental outcome examining total SHBG in fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Dihydrotestosterone (DHT)
Experimental outcome examining total DHT in fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in White Blood Cell count
Experimental outcome examining total White Blood Cell count via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Red Blood Cell count
Experimental outcome examining total Red Blood Cell count via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Hemoglobin levels
Experimental outcome examining total Hemoglobin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Hematocrit levels
Experimental outcome examining total Hematocrit via fasted whole blood samples
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Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Volume
Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin
Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin Concentration
Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Red Cell Distribution Width
Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Platelet Count
Experimental outcome examining total Platelet count via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Mean Platelet Volume
Experimental outcome examining total Mean Platelet volume via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Granulocyte levels
Experimental outcome examining percentage of Granulocytes via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Lymphocytes levels
Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Monocyte levels
Experimental outcome examining percentage of Monocytes via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Eosinophil levels
Experimental outcome examining percentage of Eosinophil via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Basophil levels
Experimental outcome examining percentage of Basophil via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Granulocyte count
Experimental outcome examining total Granulocyte via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Lymphocytes count
Experimental outcome examining total Lymphocytes via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Monocyte count
Experimental outcome examining total Monocytes via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Eosinophil count
Experimental outcome examining total Eosinophil via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Basophil count
Experimental outcome examining total Basophil via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Glucose levels
Experimental outcome examining total Glucose via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Blood Urea Nitrogen levels
Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Serum Creatinine levels
Experimental outcome examining total Serum Creatinine via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Sodium levels
Experimental outcome examining total Sodium via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Potassium levels
Experimental outcome examining total Potassium via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Chloride levels
Experimental outcome examining total Chloride via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Carbon Dioxide levels
Experimental outcome examining total Carbon Dioxide via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Calcium levels
Experimental outcome examining total Calcium via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Total Protein levels
Experimental outcome examining total Protein via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Albumin levels
Experimental outcome examining total Albumin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Globulin levels
Experimental outcome examining total Globulin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Total Bilirubin levels
Experimental outcome examining total Bilirubin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Alkaline Phosphatase levels
Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Alanine Transaminase levels
Experimental outcome examining total Alanine Transaminase via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Aspartate Aminotransferase levels
Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Albumin to Globulin ratio
Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in Blood Urea Nitrogen to Creatinine ratio
Experimental outcome examining the ratio of Blood Urea Nitrogen to Creatinine via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in estimated Glomerular Filtration Rate
Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples
Time frame: Week 0, 4, and 8
Changes in total mass
Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Lean Body Mass
Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Fat Mass
Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Bone Mineral Content
Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Bone Mineral Density
Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Body Fat Percentage
Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Body Mass Index
Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA).
Time frame: Week 0, 4, and 8
Changes in Grip Strength
Assessed using a handheld dynamometer
Time frame: Week 0, 4, and 8
Changes in Energy
Assessed through a visual analog scale (100mm line), where 0 is no energy at all and 100 is very energized
Time frame: Week 0, 4, and 8
Changes in Quality of Life
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.
Time frame: Week 0, 4, and 8
Changes in Perceived Stress
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.
Time frame: Week 0, 4, and 8
Changes in Sleep Quality
Assessed by administering the Sleep Quality Index (PSQI) for subjective measurement. Values range from 0 to 3 with lower scores demonstrating a better outcome.
Time frame: Week 0, 4, and 8
Changes in Fatigue
Assessed by administering the Multidimensional Fatigue Index for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.
Time frame: Week 0, 4, and 8
Changes in Physical Activity
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.
Time frame: Week 0, 4, and 8