2-HOBA Supplementation for High Cholesterol

Overseen By Daria Salamevich

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Cardiovascular disease, Pregnancy, Liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a natural supplement called 2-HOBA to determine its effects on individuals with high cholesterol, particularly those with elevated lipoprotein(a) levels, a type of "bad" cholesterol. Researchers aim to discover if 2-HOBA can reduce harmful oxidized lipids and enhance cholesterol function. Participants will take 2-HOBA capsules three times daily for six weeks and undergo blood and urine tests. The trial seeks adults with high lipoprotein(a) levels who can adhere to a doctor-recommended diet and maintain a stable lifestyle during the study. As an unphased trial, this study provides a unique opportunity to contribute to early research on a natural supplement that could improve cholesterol health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that 2-HOBA is likely to be safe for humans?

Research has shown that 2-hydroxybenzylamine (2-HOBA) is generally safe for people. Early studies indicate it might reduce harmful substances in the blood and suggest that 2-HOBA is well-tolerated, with most people not experiencing significant side effects.

Some individuals might have minor side effects, but these are uncommon. Since 2-HOBA comes from buckwheat seeds, a natural source, this further supports its safety. Overall, while more research is always beneficial, early findings suggest 2-HOBA is safe for people to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for high cholesterol, which typically include statins that work by inhibiting cholesterol production in the liver, 2-HOBA (Hobamine) is unique because it targets oxidative stress. Researchers are excited about 2-HOBA because it acts as an antioxidant, scavenging reactive carbonyl species that contribute to cardiovascular issues. This novel mechanism may help reduce elevated levels of lipoprotein(a), a known risk factor for heart disease, with potentially fewer side effects than traditional therapies.

What evidence suggests that 2-HOBA might be an effective treatment for high cholesterol?

Research has shown that 2-HOBA might help reduce harmful fats in people with high levels of lipoprotein(a), a type of cholesterol. In animal studies, 2-HOBA improved signs of inflammation and lowered other harmful effects, such as high blood sugar. These findings suggest that 2-HOBA might aid in addressing inflammation and blood clotting problems. Early human trials, including this trial where participants will take 2-HOBA supplementation, are also examining whether it can improve the function of certain blood fats. Although more research is needed, these early findings offer promise for people with high cholesterol and related health issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Wenliang Song, MD

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

This trial is for adults with high levels of lipoprotein(a), a type of cholesterol linked to heart disease. Participants will take 2-HOBA capsules and provide blood and urine samples. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Elevated Lp(a) levels ≥ 90 mg/dL

Able to provide informed consent and adhere to study schedules

Willing to follow a physician-recommended diet during the study

Exclusion Criteria

Pregnant, planning pregnancy during the study period, or currently breastfeeding

Planning major changes in diet or exercise routines

Experienced >20% weight change in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 2-HOBA capsules (400 mg, three times daily with meals) for 6 weeks

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 2-HOBA

Trial Overview The study tests if the natural supplement 2-HOBA can lower harmful oxidized lipids in people with elevated lipoprotein(a). It also looks at whether it reduces inflammation and blood clotting markers over a period of six weeks.

How Is the Trial Designed?

Group I: 2-HOBA Supplementation for Elevated Lipoprotein(a) Experimental Treatment 1 Intervention

Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine) at a dose of 400 mg three times daily with meals for 6 weeks.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07198009

2-HOBA Supplementation in People With Elevated ... This pilot clinical trial will test whether oral 2-HOBA supplementation can improve the biology of Lp(a) in people with high levels (≥90 mg/dL).

2. withpower.com withpower.com/trial/phase-hyperlipidemias-10-2025-17e94

2-HOBA Supplementation for High Cholesterol Trial Overview The study tests if the natural supplement 2-HOBA can lower harmful oxidized lipids in people with elevated lipoprotein(a). It also looks at ...

3. mdpi.com mdpi.com/2072-6643/17/4/610

Reactive Dicarbonyl Scavenging with 2- ... In STAM (Stelic Animal Model) mice, 2-HOBA improved NAFLD activity scores (p = 0.03, NAS), hyperglycemia, and inflammatory cytokines and reduced serum F2- ...

4. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-2-hoba-supplementation-in-people-with-elevated-lipoprotein-a-/555763865

Clinical Trial: 2-HOBA Supplementation in People With ... The main questions it aims to answer are: Does 2-HOBA lower oxidized phospholipids on lipoprotein(a)? Does 2-HOBA reduce markers of inflammation ...

5. trial.medpath.com trial.medpath.com/clinical-trial/c6be05ba616b58c1/nct04941599-2-hydroxybenzylamine-reduce-hdl-modification-familial-hypercholesterolemia

2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification ... The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH.

6. biorxiv.org biorxiv.org/content/10.1101/524884v2.full-text

Scavenging of reactive dicarbonyls with 2- ... A similar reduction in atherosclerosis was observed when male Ldlr−/− mice were treated with 3 g/L of 2-HOBA (Data not shown). Thus, for the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04941599

2-Hydroxybenzylamine (2-HOBA) to Reduce HDL ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... 2-HOBA increases HDL cholesterol efflux capacity. Change in HDL cholesterol ...