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

Overseen By Raad Gheith, M.A

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Applied Science & Performance Institute

Must not be taking: Anti-diabetic, Anti-platelet, Beta blockers, others

Disqualifiers: Cardiovascular, Neurological, Metabolic, others

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

83 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a dietary supplement called Geranylgeraniol to see if it can improve sexual health in males and females. The supplement might help by balancing hormones and improving physical health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes those using drugs that are anti-diabetic, anti-platelet, anti-coagulant, beta blockers, or used to treat erectile dysfunction (ED).

What makes the drug Geranylgeraniol (GG) from Annatto unique compared to other treatments?

Geranylgeraniol (GG) from Annatto is unique because it is derived from a natural source and may offer a novel mechanism of action by utilizing prenylation, a process that enhances the biological activity of compounds, which is not commonly seen in standard treatments. ^{1 2 3 4 5}

Eligibility Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants are baseline assessed on sexual health function, body composition, blood chemistry, and grip strength

1 week

1 visit (in-person)

Treatment

Participants receive Geranylgeraniol or placebo supplementation with dose escalation over 8 weeks

8 weeks

3 visits (in-person) at weeks 0, 4, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Geranylgeraniol (GG) sourced from Annatto

Participant Groups

Group I: Geranylgeraniol Treatment Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Applied Science & Performance Institute

Lead Sponsor

Trials

17

Recruited

1,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Characterization of coumarin-specific prenyltransferase activities in Citrus limon peel. [2017]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Leaf Ests from Stevia rebaudiana: a resource for gene discovery in diterpene synthesis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Phenylpropanoid interconversion in Anigozanthos preissii observed by high-performance liquid chromatography-nuclear magnetic resonance spectroscopy. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Two UGT84 Family Glycosyltransferases Catalyze a Critical Reaction of Hydrolyzable Tannin Biosynthesis in Pomegranate (Punica granatum). [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Characterization of a UGT84 Family Glycosyltransferase Provides New Insights into Substrate Binding and Reactivity of Galloylglucose Ester-Forming UGTs. [2019]