Geranylgeraniol for Sexual Wellness

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called Geranylgeraniol, derived from Annatto, can improve sexual health in men and women. Participants will take either the supplement or a placebo (a non-active substance) for eight weeks, with a gradual dose increase halfway through. It targets individuals aged 30 to 49 experiencing symptoms affecting sexual health. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance sexual health solutions.

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).

Is there any evidence suggesting that Geranylgeraniol supplementation is likely to be safe?

Research has shown that Geranylgeraniol (GG) is generally safe for people. One study found that GG did not cause significant changes in blood tests or hormone levels in men and women, indicating no major changes in important blood markers—a positive sign for safety.

Although detailed safety studies are not widely available, GG is often used as a supplement for healthy aging and energy, suggesting it is well-tolerated.

Overall, GG from Annatto appears safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for sexual health that often involve pharmaceuticals like PDE5 inhibitors (such as Viagra or Cialis), this new approach uses geranylgeraniol (GG) sourced from annatto, a natural product. Researchers are excited about GG because it offers a potential alternative with a different mechanism of action, possibly interacting with the body's natural processes in a novel way. Additionally, GG is derived from a plant source, which may appeal to those seeking more natural treatment options.

What evidence suggests that Geranylgeraniol might be an effective treatment for sexual health function?

Research suggests that Geranylgeraniol (GG) might improve sexual health by balancing hormones. Although studies have not shown major changes in blood tests or hormone levels, GG is being explored for its unique mechanism. Early signs indicate it could positively affect sexual health. Participants in this trial will receive either Geranylgeraniol or a placebo. GG has a strong safety record, as it is considered safe even at much higher doses than those being tested. This treatment remains under study, so results are not yet confirmed, but the potential benefits make it worth exploring. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Geranylgeraniol (GG) sourced from Annatto

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6022510/

A 12-week evaluation of annatto tocotrienol supplementation ... Annatto-derived tocotrienol up to 600 mg per day for 12 weeks appeared to be safe in postmenopausal osteopenic women, particularly in terms of liver and kidney ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05258513

The Effects of Geranylgeraniol (GG) Sourced From Annatto ... This study examines the effectiveness of Geranylgeraniol on sexual health in males and females, using an 8-week dose escalation, with a placebo group.

3. mdpi.com mdpi.com/1661-3821/3/4/43

The Effects of Geranylgeraniol on Blood Safety and Sex ... This study demonstrates that GG does not significantly change the composition of blood chemistry, hematology, or sex hormone profiles in adult males or females.

4. withpower.com withpower.com/trial/phase-libido-2-2022-80a5e

The Effects of Geranylgeraniol (GG) Sourced From Annatto ... This trial tests Geranylgeraniol (GG) to improve sexual health in males and females, potentially by balancing hormones and using a unique mechanism.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027323002100115X

A toxicological evaluation of geranylgeraniol The no observed adverse effect level for systemic toxicity in the 90-day study was 725 mg/kg bw/day. Abstract. Geranylgeraniol (GGOH) is an isoprenoid compound ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8911567/

In Silico Studies with Geranylgeraniol and Tocotrienols Annatto compounds, geranylgeraniol and tocotrienols, show potential against hyperlipidemia and chronic diseases, with anti-inflammatory and ...

7. amazon.com amazon.com/Designs-Health-Annatto-GG-300-Geranylgeraniol/dp/B0CM6NVRYX

Designs for Health Annatto-GG 300 - Geranylgeraniol ... This supplement supports healthy aging, bone, muscle, and cellular energy, and promotes GG replenishment, with 300mg of trans-geranylgeraniol per serving.