The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health

Study Overview
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Brief Summary
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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
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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)

Official Title
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The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females

Conditions
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Libido, Sexual Health

Intervention / Treatment
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* Dietary Supplement: Placebo Supplementation
* Dietary Supplement: GG sourced from Annatto


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, parallel, randomized, placebo controlled, dose-escalation trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo Supplementation<br>* 8 weeks of placebo supplementation<br>|
| Experimental: Geranylgeraniol Treatment<br>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. | Dietary Supplement: GG sourced from Annatto<br>* 8-weeks of Geranylgeraniol supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 0, 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone | Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples | Week 0, 4, and 8 | 
| Estradiol | Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples | Week 0, 4, and 8 | 
| Progesterone | Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples | Week 0, 4, and 8 | 
| Sex Hormone Binding Globulin (SHBG) | Experimental outcome examining total SHBG in fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Dihydrotestosterone (DHT) | Experimental outcome examining total DHT in fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in White Blood Cell count | Experimental outcome examining total White Blood Cell count via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Red Blood Cell count | Experimental outcome examining total Red Blood Cell count via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Hemoglobin levels | Experimental outcome examining total Hemoglobin via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Hematocrit levels | Experimental outcome examining total Hematocrit via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Mean Corpuscular Volume | Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Mean Corpuscular Hemoglobin | Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Mean Corpuscular Hemoglobin Concentration | Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Red Cell Distribution Width | Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Platelet Count | Experimental outcome examining total Platelet count via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Mean Platelet Volume | Experimental outcome examining total Mean Platelet volume via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Granulocyte levels | Experimental outcome examining percentage of Granulocytes via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Lymphocytes levels | Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Monocyte levels | Experimental outcome examining percentage of Monocytes via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Eosinophil levels | Experimental outcome examining percentage of Eosinophil via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Basophil levels | Experimental outcome examining percentage of Basophil via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Granulocyte count | Experimental outcome examining total Granulocyte via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Lymphocytes count | Experimental outcome examining total Lymphocytes via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Monocyte count | Experimental outcome examining total Monocytes via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Eosinophil count | Experimental outcome examining total Eosinophil via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Basophil count | Experimental outcome examining total Basophil via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Glucose levels | Experimental outcome examining total Glucose via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Blood Urea Nitrogen levels | Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Serum Creatinine levels | Experimental outcome examining total Serum Creatinine via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Sodium levels | Experimental outcome examining total Sodium via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Potassium levels | Experimental outcome examining total Potassium via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Chloride levels | Experimental outcome examining total Chloride via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Carbon Dioxide levels | Experimental outcome examining total Carbon Dioxide via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Calcium levels | Experimental outcome examining total Calcium via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Total Protein levels | Experimental outcome examining total Protein via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Albumin levels | Experimental outcome examining total Albumin via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Globulin levels | Experimental outcome examining total Globulin via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Total Bilirubin levels | Experimental outcome examining total Bilirubin via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Alkaline Phosphatase levels | Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Alanine Transaminase levels | Experimental outcome examining total Alanine Transaminase via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in Aspartate Aminotransferase levels | Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples | 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 | 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 | Week 0, 4, and 8 | 
| Changes in estimated Glomerular Filtration Rate | Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples | Week 0, 4, and 8 | 
| Changes in total mass | Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Lean Body Mass | Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Fat Mass | Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Bone Mineral Content | Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Bone Mineral Density | Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Body Fat Percentage | Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Body Mass Index | Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA). | Week 0, 4, and 8 | 
| Changes in Grip Strength | Assessed using a handheld dynamometer | 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 | 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. | 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. | 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. | 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. | 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. | Week 0, 4, and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Health, Libido, Vitality, Hormones, Body Composition, Strength