Dietary Supplements for Health

Not currently recruiting at 5 trial locations
CD
Overseen ByChris D'Adamo, Ph.D.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well different dietary supplements boost coenzyme Q10 (CoQ10) levels and improve overall health. Participants will try one of four supplements—Geranylgeraniol, Ubiquinol, Ubiquinol with Geranylgeraniol, or Ubiquinone—or a placebo. It is ideal for adults over 40 who do not regularly use CoQ10 supplements, are not on certain medications, and do not have specific chronic health issues. The trial will last 8 weeks, helping researchers determine which supplements might be most effective. As a Phase 2, Phase 3 trial, this study assesses the supplements' effectiveness in a larger group and serves as the final step before potential FDA approval, offering participants a chance to contribute to significant health advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. If you are currently using statins, H2 blockers, PPIs, or bisphosphonates daily, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the dietary supplements in this trial—geranylgeraniol, ubiquinol, a mix of ubiquinol and geranylgeraniol, and ubiquinone—are generally safe for people.

For geranylgeraniol, studies have found it does not significantly alter blood chemistry or hormones. It is considered safe, with no harmful effects observed at high doses in animal studies.

Ubiquinol and ubiquinone, both forms of Coenzyme Q10, are well-tolerated by people. Research suggests CoQ10 is safe up to 1200 mg per day, with only mild side effects like stomach upset.

The combination of ubiquinol and geranylgeraniol has also undergone study, with no serious side effects reported.

Overall, these supplements are considered safe at the doses commonly used in studies and products.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new combinations and forms of well-known dietary supplements, like ubiquinol, geranylgeraniol, and ubiquinone. Unlike the standard CoQ10 supplements, ubiquinol is a more bioavailable version, meaning it's easier for your body to use. Geranylgeraniol is gaining attention for its potential to support cellular health in ways traditional supplements don't. The unique combination of ubiquinol and geranylgeraniol might offer enhanced benefits by targeting multiple pathways related to energy production and cellular health. These innovative approaches could provide new insights and options for improving overall health and vitality.

What evidence suggests that this trial's treatments could be effective for increasing CoQ10 concentrations?

Research has shown that Ubiquinol, one of the treatments in this trial, can significantly increase CoQ10 levels in the body. Studies have found that taking 100 mg daily can raise CoQ10 levels by 222%, while 300 mg can lead to a 777% increase. Ubiquinone, another treatment option in this trial, supports heart health and may help lower blood pressure. Geranylgeraniol, also under study in this trial, is believed to boost CoQ10 production and may benefit muscle health. When Ubiquinol and Geranylgeraniol are used together, as in one of the trial arms, they may enhance energy production in cells. Various studies have shown promising results for these supplements, supporting their potential to increase CoQ10 and improve health.36789

Are You a Good Fit for This Trial?

This trial is for individuals interested in improving their health and wellness. Participants should be willing to take dietary supplements or a placebo for 8 weeks. There are no specific inclusion criteria provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am 40 years old or older.

Exclusion Criteria

Participant in a clinical trial in the previous 30 days
I use acid reflux medication daily.
I am currently taking bisphosphonates every day.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four dietary supplements or placebo for 8 weeks to assess CoQ10 concentrations

8 weeks
Baseline and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Geranylgeraniol
  • Placebo
  • Ubiquinol
  • Ubiquinol + geranylgeraniol
  • Ubiquinone
Trial Overview The study tests the safety and effectiveness of four dietary supplements: Ubiquinol with geranylgeraniol, Ubiquinone alone, Ubiquinol alone, Geranylgeraniol alone, against a placebo. The goal is to see which one increases CoQ10 levels best over an 8-week period.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Ubiquinone (NOW CoQ10 200mg)Experimental Treatment1 Intervention
Group II: Ubiquinol + geranylgeraniol combination (Designs for Health - CoQnol™ 200)Experimental Treatment1 Intervention
Group III: Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)Experimental Treatment1 Intervention
Group IV: Geranylgeraniol (Annatto-GG™ 300)Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

OvationLab

Lead Sponsor

Trials
1
Recruited
150+

Citations

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.
Beneficial effect of dietary geranylgeraniol on glucose ...The previous studies strongly suggest that GGOH supplementation would benefit glucose homeostasis and bone health, probably in part through modulating the ...
The Effects of Geranylgeraniol on Blood Safety and Sex ...Geranylgeraniol has demonstrated anti-inflammatory and antinociceptive properties and previous research has reported GG to potentially improve ...
Geranylgeraniol supplementation leads to an improvement ...This first reported pilot study evaluates the safety and efficacy of dietary geranylgeraniol supplementation (GG) in three patients with HIDS.
Beneficial effect of dietary geranylgeraniol on glucose ...The previous studies strongly suggest that GGOH supplementation would benefit glucose homeostasis and bone health, probably in part through modulating the ...
SAFETY DATA SHEETSAFETY DATA SHEET. TRC-G367499-500MG - Geranylgeraniol (Natural). ~85%. Revision date 16-Jun-2023. European Food Safety Authority (EFSA). EPA (Environmental ...
Geranylgeraniol Supplementation in Patients With ...This study evaluates the safety and efficacy of dietary geranylgeraniol (GG) supplementation in patients with genetically confirmed mevalonate kinase deficiency ...
A toxicological evaluation of geranylgeraniolGeranygeraniol 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.
Geranylgeraniol (GG) Supplementation and Its Impact on ...Participate in this study to help us learn about how Geranylgeraniol (GG) can impact your body composition and exercise performance.
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