Geranylgeraniol for Health

Overseen By Michael Jurgelewicz, DC, CNS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Designs for Health

Must not be taking: NSAIDS, Statins, Blood thinners, others

Disqualifiers: Diabetes, Cancer, Heart disorders, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if geranylgeraniol (GG), a supplement, can boost testosterone levels in healthy middle-aged men and women. Researchers hope GG will not only increase testosterone but also enhance participants' overall well-being. The trial includes two groups: one will take GG, and the other will receive a placebo (a pill with no active ingredient) for comparison. Ideal participants are healthy individuals aged 40 to 65 who are not taking certain supplements or medications and have no significant health issues. As an unphased trial, this study allows participants to contribute to groundbreaking research on natural supplements and overall well-being.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including NSAIDs, statins, blood thinners, H2 blockers, PPIs, and blood sugar-lowering agents, to participate in this trial.

What prior data suggests that geranylgeraniol is safe for middle-aged individuals?

Research has shown that geranylgeraniol (GG) is generally safe and does not cause genetic damage. In animal tests, even high doses caused no harm. Specifically, no negative effects appeared at doses up to 725 mg per kilogram of body weight per day over 90 days.

However, GG can irritate the skin, eyes, and respiratory system if not handled correctly. Currently, no evidence points to serious long-term safety issues. This suggests GG is well-tolerated, but participants should still follow safety guidelines during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Geranylgeraniol is unique because it introduces a new active ingredient that isn't commonly used in existing treatments for related conditions. Unlike standard treatments that might focus on general symptom relief or other pathways, geranylgeraniol targets a specific biochemical process involved in cellular health and maintenance. Researchers are excited about its potential to improve health at a cellular level, offering a novel approach that could complement or enhance current therapeutic options. This innovative mechanism of action has the potential to address underlying issues that other treatments might not fully target.

What evidence suggests that geranylgeraniol could be effective for enhancing testosterone levels?

Research has shown that geranylgeraniol (GG) might offer health benefits, such as reducing inflammation and supporting bone health. Some studies have examined GG's effects on sexual health, but little information exists on its specific impact on testosterone levels. However, GG has shown promise in improving bone strength and addressing obesity-related issues. These benefits suggest that GG could enhance overall health, potentially helping to maintain healthy testosterone levels indirectly. While more research is needed to confirm its effect on testosterone, GG's overall health benefits make it a supplement worth exploring further. Participants in this trial will receive either geranylgeraniol or a placebo to evaluate these potential health benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 40 to 65 who want to explore if taking Geranylgeraniol (GG) can boost their testosterone levels. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am between 40 and 65 years old.

I don't have a history of serious digestive, liver, or kidney diseases.

Negative pregnancy test confirmed with serum HCG on initial baseline testing and baseline testing at the start of the crossover (at 10 weeks)

Exclusion Criteria

I have taken CoQ10 or Ubiquinol supplements in the last 2 weeks.

I haven't taken hormone supplements like fenugreek or ashwagandha in the last 4 weeks.

Hemophilia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either geranylgeraniol (GG) supplementation or placebo for 8 weeks

8 weeks

3 visits (in-person) at baseline, 8 weeks, and 10 weeks

Washout

A 2-week washout period where no treatment is administered

2 weeks

Treatment Period 2

Participants receive the alternate treatment (either geranylgeraniol or placebo) for another 8 weeks

8 weeks

2 visits (in-person) at 10 weeks and 18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Geranylgeraniol

Trial Overview The study tests whether a supplement called Geranylgeraniol (GG) at a dose of 300 mg can increase testosterone levels over an 18-week period, compared with a placebo. Participants will switch between the GG supplement and the placebo at some point in the crossover design.

How Is the Trial Designed?

Group I: Geranylgeraniol 300 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Designs for Health

Lead Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

Geranylgeraniol (GGOH) significantly improved the viability and migration ability of endothelial progenitor cells (EPC) that were negatively affected by nitrogen-containing bisphosphonates (N-BPs), suggesting its potential as a treatment for bisphosphonate-associated osteonecrosis of the jaws (BP-ONJ).

The study demonstrated that GGOH treatment reduced apoptosis rates in EPC exposed to N-BPs, indicating that it may help counteract the harmful effects of these medications on bone healing and regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoprenoid geranylgeraniol: the influence on cell characteristics of endothelial progenitor cells after bisphosphonate therapy in vitro. Pabst, AM., Krüger, M., Ziebart, T., et al.[2018]

A 10-day diet supplemented with geranylgeraniol (GGOH) in rats significantly reduced inflammation and liver damage by inhibiting the activation of NF-κB signaling, as evidenced by lower levels of inflammatory cytokines and liver enzymes.

GGOH supplementation led to decreased expression of key signaling molecules involved in NF-κB activation, such as IRAK1 and TRAF6, demonstrating its potential as a protective agent against liver inflammation and damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplementation with geranylgeraniol suppresses lipopolysaccharide-induced inflammation via inhibition of nuclear factor-κB activation in rats. Giriwono, PE., Shirakawa, H., Ohsaki, Y., et al.[2021]

Geranylgeraniol (GGOH), a safe food substance, promotes the differentiation of muscle cells (myoblasts) without harming their growth, suggesting potential benefits for muscle health.

GGOH reduces the expression of proteins associated with muscle atrophy, indicating its role in supporting muscle maintenance and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geranylgeraniol-induced Myogenic Differentiation of C2C12 Cells. Matsubara, T., Urata, M., Nakajima, T., et al.[2020]

Medication-related osteonecrosis of the jaw (ONJ) is a serious side effect of bisphosphonates, which are commonly used to treat cancer and osteoporosis by inhibiting bone resorption.

Geranylgeraniol (GGOH) shows promise as a topical treatment to mitigate bisphosphonate-related ONJ by supporting the bone healing process, but further research is needed to establish effective delivery methods and validate its use in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Geranylgeraniol in Managing Bisphosphonate-Related Osteonecrosis of the Jaw. Chin, KY., Ekeuku, SO., Trias, A.[2022]

Geranylgeraniol (GGO) induces apoptosis in human leukemia HL60 cells, and this process is linked to intracellular acidification, indicating a potential mechanism for its anti-cancer effects.

The induction of apoptosis by GGO is dependent on early changes in intracellular calcium levels and a decrease in pH, as shown by the inhibition of these effects when using specific inhibitors like TPA and BAPTA-AM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increase in intracellular Ca(2+) concentrations and the corresponding intracellular acidification are early steps for induction of apoptosis by geranylgeraniol in HL60 cells. Masuda, Y., Aiuchi, T., Mihara, S., et al.[2019]

Geranylgeraniol effectively suppresses the growth of human prostate carcinoma cells, with an IC50 value of 80±18 µmol/L after 72 hours, indicating its potential as a therapeutic agent.

The mechanism of action involves inducing cell cycle arrest at the G1 phase and promoting apoptosis, which is linked to a decrease in the level of HMG CoA reductase protein, suggesting that targeting this enzyme could be a strategy for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geranylgeraniol suppresses the viability of human DU145 prostate carcinoma cells and the level of HMG CoA reductase. Fernandes, NV., Yeganehjoo, H., Katuru, R., et al.[2021]

Geranylgeraniol effectively suppresses the growth of B16 melanoma cells in a dose-dependent manner, with an IC(50) of 55 µmol/L, by inducing cell cycle arrest and apoptosis.

The growth suppression is linked to the depletion of mevalonate, a crucial product of HMG-CoA reductase, suggesting that targeting this pathway could enhance the therapeutic potential of geranylgeraniol in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mevalonate depletion mediates the suppressive impact of geranylgeraniol on murine B16 melanoma cells. Katuru, R., Fernandes, NV., Elfakhani, M., et al.[2015]

Geranylgeraniol, a natural compound from Pterodon pubescens fruit oil, has been shown to inhibit platelet aggregation, particularly in the arachidonic acid pathway, indicating its potential as an anti-inflammatory agent.

The study reveals that geranylgeraniol works by inhibiting the cyclooxygenase enzyme, which is crucial in the metabolism of arachidonic acid, thus providing a new understanding of its mechanism of action in reducing platelet activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of geranylgeraniol isolated from Pterodon pubescens fruit oil is mediated by inhibition of cyclooxygenase-1. Calixto, NO., da Costa e Silva, MC., Gayer, CR., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8464510/

Beneficial effect of dietary geranylgeraniol on glucose ... In this study, we demonstrated that GGOH's beneficial impact on anti-obesity, glucose homeostasis, and bone remodeling seems to be associated with the favorable ...

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

The Effects of Geranylgeraniol on Blood Safety and Sex ... Previous studies have reported the potential health benefits of GG supplementation to include anti-inflammatory and antinociceptive properties ...

3. 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.

4. musechem.com musechem.com/blog/the-science-of-geranylgeraniol-why-it-matters-for-your-health/?srsltid=AfmBOorJUOH2Yk4dpjRiPKCUiAfD1-uaKghrCzloi4czuUiLRbErqacq

The Science of Geranylgeraniol (GGOH) – Benefits for ... Health Benefits of Geranylgeraniol (GGOH) · 1. Supports Bone Health & Osteoporosis Prevention · 2. Aids in Cholesterol & Lipid Metabolism · 3.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531721000439

Beneficial effect of dietary geranylgeraniol on glucose ... Geranylgeraniol (GGOH) alleviates obesity-associated glucose intolerance. · GGOH improved the bone microstructure in obese mice · GGOH decreased Dorea longicatena ...

6. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-W011474R/Geranylgeraniol-Standard-SDS-MedChemExpress.pdf

Geranylgeraniol (Standard) Rinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician. Inhalation. Safety Data Sheet.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34144118/

A toxicological evaluation of geranylgeraniol Toxicological studies on its safety profile are not readily available. ... No evidence of mutagenicity or genotoxic activity was observed under the applied test ...

8. lgcstandards.com lgcstandards.com/medias/sys_master/root/hbf/he0/11006811242526/SDS_TRC-G367499-500MG_ST-WB-MSDS-5101251-1-1-1/SDS-TRC-G367499-500MG-ST-WB-MSDS-5101251-1-1-1.PDF

SAFETY DATA SHEET Delayed and immediate effects as well as chronic effects from short and long-term exposure. Skin corrosion/irritation. Classification based on data available ...

9. chemicalbook.com chemicalbook.com/msds/geranylgeraniol.pdf

geranylgeraniol.pdf Hazard statement(s). H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation. Precautionary statement(s).

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

A toxicological evaluation of geranylgeraniol Geranygeraniol showed no in vivo genotoxicity. ... The no observed adverse effect level for systemic toxicity in the 90-day study was 725 mg/kg bw/day. Abstract.