The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
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About
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.
Full 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)
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 2 patient groups, including a placebo group
Trial contacts and locations
There are currently no registered sites for this trial.
Timeline
Last updated: Dec 29, 2022Start date
Feb 06, 2022 • 3 years ago
End date
Dec 09, 2022 • 2 years ago
Today
May 02, 2025
Sponsor of this trial
Lead Sponsor
Data sourced from clinicaltrials.gov
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