The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Changes in Erection Hardness
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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
Outcomes
Primary Outcomes
Changes in Erection Hardness
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Sex Hormone Binding Globulin (SHBG)(Week 0, 4, and 8)
- Changes in Red Cell Distribution Width(Week 0, 4, and 8)
- Changes in Dihydrotestosterone (DHT)(Week 0, 4, and 8)
- Testosterone(Week 0, 4, and 8)
- Estradiol(Week 0, 4, and 8)
- Changes in White Blood Cell count(Week 0, 4, and 8)
- Changes in Lymphocytes levels(Week 0, 4, and 8)
- Changes in Granulocyte count(Week 0, 4, and 8)
- Changes in Eosinophil count(Week 0, 4, and 8)
- Changes in Basophil count(Week 0, 4, and 8)
- Changes in Albumin levels(Week 0, 4, and 8)
- Changes in Red Blood Cell count(Week 0, 4, and 8)
- Changes in Mean Corpuscular Volume(Week 0, 4, and 8)
- Changes in Mean Corpuscular Hemoglobin(Week 0, 4, and 8)
- Changes in Platelet Count(Week 0, 4, and 8)
- Changes in Serum Creatinine levels(Week 0, 4, and 8)
- Changes in Sodium levels(Week 0, 4, and 8)
- Changes in Potassium levels(Week 0, 4, and 8)
- Changes in Total Bilirubin levels(Week 0, 4, and 8)
- Changes in Alkaline Phosphatase levels(Week 0, 4, and 8)
- Changes in total mass(Week 0, 4, and 8)
- Progesterone(Week 0, 4, and 8)
- Changes in Hemoglobin levels(Week 0, 4, and 8)
- Changes in Hematocrit levels(Week 0, 4, and 8)
- Changes in Mean Corpuscular Hemoglobin Concentration(Week 0, 4, and 8)
- Changes in Granulocyte levels(Week 0, 4, and 8)
- Changes in Monocyte levels(Week 0, 4, and 8)
- Changes in Monocyte count(Week 0, 4, and 8)
- Changes in Mean Platelet Volume(Week 0, 4, and 8)
- Changes in Eosinophil levels(Week 0, 4, and 8)
- Changes in Basophil levels(Week 0, 4, and 8)
- Changes in Lymphocytes count(Week 0, 4, and 8)
- Changes in Glucose levels(Week 0, 4, and 8)
- Changes in Blood Urea Nitrogen levels(Week 0, 4, and 8)
- Changes in Chloride levels(Week 0, 4, and 8)
- Changes in Carbon Dioxide levels(Week 0, 4, and 8)
- Changes in Calcium levels(Week 0, 4, and 8)
- Changes in Total Protein levels(Week 0, 4, and 8)
- Changes in Globulin levels(Week 0, 4, and 8)
- Changes in Alanine Transaminase levels(Week 0, 4, and 8)
- Changes in Aspartate Aminotransferase levels(Week 0, 4, and 8)
- Changes in Blood Urea Nitrogen to Creatinine ratio(Week 0, 4, and 8)
- Changes in Energy(Week 0, 4, and 8)
- Changes in Physical Activity(Week 0, 4, and 8)
- Changes in Albumin to Globulin ratio(Week 0, 4, and 8)
- Changes in estimated Glomerular Filtration Rate(Week 0, 4, and 8)
- Changes in Lean Body Mass(Week 0, 4, and 8)
- Changes in Fat Mass(Week 0, 4, and 8)
- Changes in Body Fat Percentage(Week 0, 4, and 8)
- Changes in Body Mass Index(Week 0, 4, and 8)
- Changes in Grip Strength(Week 0, 4, and 8)
- Changes in Bone Mineral Content(Week 0, 4, and 8)
- Changes in Quality of Life(Week 0, 4, and 8)
- Changes in Sleep Quality(Week 0, 4, and 8)
- Changes in Fatigue(Week 0, 4, and 8)
- Changes in Bone Mineral Density(Week 0, 4, and 8)
- Changes in Perceived Stress(Week 0, 4, and 8)