Nattokinase & Red Yeast Rice for Cholesterol?

observational-study PMID: 19786378

Quick Summary: Research suggests a combination of nattokinase and red yeast rice may help lower cholesterol, but nattokinase alone didn't show the same benefits. This study looked at people with high cholesterol.

Does Nattokinase Lower Cholesterol?

This study found that taking nattokinase with red yeast rice significantly improved cholesterol levels. However, nattokinase by itself didn't have a big impact on cholesterol.

What The Research Found

The study compared three groups: one taking nattokinase alone, one taking nattokinase combined with red yeast rice, and a placebo (a "dummy" pill). Here's what they found:

Nattokinase and Red Yeast Rice Combo:

Lowered "bad" LDL cholesterol by 41%
Reduced total cholesterol by 25%
Decreased triglycerides (another type of fat in the blood) by 15%
Increased "good" HDL cholesterol by 7.5%

Nattokinase Alone: Showed no significant changes in cholesterol levels.

Study Details

Who was studied: 47 people with high cholesterol (hyperlipidemia).

How long: The study lasted for 6 months.

What they took:

Nattokinase only group: 100mg of nattokinase per day.
Nattokinase and Red Yeast Rice group: 100mg of nattokinase and 600mg of red yeast rice per day.
Placebo group: A "dummy" pill.

What This Means For You

If you're looking to lower your cholesterol, this study suggests that nattokinase alone may not be effective.

The combination of nattokinase and red yeast rice did show positive results. However, red yeast rice contains a substance similar to statin drugs, which can have side effects.

Always talk to your doctor before taking any supplements, especially if you have high cholesterol or are taking other medications. They can help you determine the best course of action for your health.

Study Limitations

The study was small, involving only 47 people.

The study didn't provide information about the participants' ages, sex, or other health details.

The dose of nattokinase used in the study was relatively low.

The red yeast rice component is likely responsible for the cholesterol-lowering effects, not the nattokinase.

Red yeast rice can have side effects similar to statin drugs.

Key Findings

The study concluded that nattokinase alone (100 mg/day) showed no significant lipid-lowering effects over six months in hyperlipidemic patients. In contrast, nattokinase combined with red yeast rice (RYR) extract (600 mg RYR + 100 mg nattokinase/day) significantly reduced multiple lipid markers starting at month one. Key improvements included:
- LDL-C ↓ 41%
- Total cholesterol (TC) ↓ 25%
- Triglycerides (TG) ↓ 15%
- TC/HDL-C ratio ↓ 29.5%
- HDL-C ↑ 7.5%
These effects were sustained through month six. Only the combo group showed statistically significant differences versus placebo for TC, LDL-C, and TC/HDL-C ratio (p<0.0001) after baseline adjustment.

Study Design

This was a 6-month randomized, double-blind, placebo-controlled parallel-group trial involving 47 human subjects with hyperlipidemia. Participants were assigned to:
1. Nattokinase-mono group (n = ?)
2. Nattokinase + RYR combo group (n = ?)
3. Placebo group (n = ?)
No demographic details (age, sex, baseline lipid levels) were provided beyond hyperlipidemia diagnosis.

Dosage & Administration

Nattokinase-mono: 50 mg/capsule, 2 capsules twice daily (100 mg/day total)
Combo formula: 300 mg RYR extract + 50 mg nattokinase/capsule, 2 capsules twice daily (600 mg RYR + 100 mg nattokinase/day total)
Placebo: Identical inert capsules
All groups took 4 capsules daily for 6 months.

Results & Efficacy

The combo group demonstrated significant lipid improvements versus placebo (p<0.0001 for TC, LDL-C, TC/HDL-C ratio after baseline adjustment):
- LDL-C: 41% reduction (from baseline)
- TC: 25% reduction
- TG: 15% reduction
- TC/HDL-C ratio: 29.5% reduction
- HDL-C: 7.5% increase
Nattokinase monotherapy showed no statistically significant changes in any lipid parameter versus placebo at any timepoint until month six, where minimal effects emerged without reported p-values.

Limitations

Small sample size (47 total participants) limits statistical power and generalizability.
Incomplete group allocation data (exact n per group not specified).
Lack of demographic details (age, sex, diet, medication use) obscures subgroup analysis.
Nattokinase dose likely subtherapeutic (100 mg/day), below typical doses (2,000 FU/day ≈ 100–200 mg) used in other studies.
No safety/adverse event data reported.
RYR composition variability: RYR contains monacolin K (a statin analog), which likely drove efficacy—confounding nattokinase’s role.

Clinical Relevance

This study does not support nattokinase monotherapy for hyperlipidemia at the tested dose (100 mg/day). The significant lipid reductions observed were attributable to the RYR component, not nattokinase. Users should note:
- RYR supplements carry risks similar to statins (e.g., myopathy, drug interactions) due to monacolin K.
- Regulatory agencies (e.g., FDA) often classify high-monacolin K RYR as unapproved drugs.
- Nattokinase alone, at this dose, showed no clinically meaningful benefit. Patients seeking lipid management should consult healthcare providers about evidence-based therapies (e.g., prescription statins) rather than relying on this combo formula.