The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
NCT ID: NCT05258513
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2022-02-06
2022-12-09
Brief Summary
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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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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
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.
Placebo Supplementation
8 weeks of placebo supplementation
Geranylgeraniol Treatment
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.
GG sourced from Annatto
8-weeks of Geranylgeraniol supplementation
Interventions
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Placebo Supplementation
8 weeks of placebo supplementation
GG sourced from Annatto
8-weeks of Geranylgeraniol supplementation
Eligibility Criteria
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Inclusion Criteria
* Males scoring 27-36 on the Aging Males Symptoms scale
* Willing to sign the Informed Consent
* English literate
Exclusion Criteria
* 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
30 Years
49 Years
ALL
Yes
Sponsors
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Applied Science & Performance Institute
INDUSTRY
Responsible Party
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Locations
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Applied Science and Performance Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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122102
Identifier Type: -
Identifier Source: org_study_id