Proposal: Assessing the Use of Psyllium Husk for the Reduction of Lipoprotein(a) in Humans

Background and Significance
Lipoprotein(a) [Lp(a)] is a low-density lipoprotein variant whose elevated levels are strongly associated with an increased risk of cardiovascular diseases (CVD), including atherosclerosis and stroke. Unlike other lipoproteins, Lp(a) levels are primarily determined genetically, and effective therapeutic options for reducing Lp(a) remain limited. Psyllium husk, derived from the seeds of Plantago ovata, is a soluble dietary fiber well-known for its cholesterol-lowering properties and improving lipid profiles. However, its potential role in modulating Lp(a) levels is not well-documented. This study aims to evaluate the efficacy of psyllium husk in reducing Lp(a) concentrations in humans.

Objective
To determine whether daily supplementation with psyllium husk significantly reduces Lp(a) levels in individuals with elevated Lp(a), and to assess its safety and tolerability over a 12-week intervention period.

Methodology

1. Study Design: Randomized, double-blind, placebo-controlled clinical trial.


2. Participants:
   

• Inclusion criteria: Adults aged 18-65 with baseline Lp(a) levels ≥50 mg/dL.


• Exclusion criteria: Use of lipid-lowering medications, chronic gastrointestinal conditions, or pregnancy.

1. Intervention:
   

• Experimental group: 10 g/day psyllium husk dissolved in water.


• Control group: Placebo (maltodextrin) matching in taste and appearance.

1. Outcome Measures:
   

• Primary outcome: Change in serum Lp(a) levels from baseline to 12 weeks.


• Secondary outcomes: Changes in total cholesterol, LDL-C, HDL-C, triglycerides, and inflammatory markers (e.g., hs-CRP).

1. Data Collection:
   

• Blood samples at baseline, 6 weeks, and 12 weeks.


• Adherence monitored through participant logs and psyllium sachet counts.

1. Statistical Analysis: Paired t-tests and ANOVA will be employed to assess differences between groups, with significance set at p<0.05.

Expected Outcomes
We hypothesize that psyllium husk supplementation will lead to a statistically significant reduction in Lp(a) levels compared to placebo, accompanied by improvements in other lipid parameters and markers of inflammation.

Implications
If successful, this study could establish psyllium husk as a cost-effective, accessible dietary intervention for managing elevated Lp(a) levels, thereby reducing the burden of cardiovascular disease globally. Further research could explore synergistic effects with other dietary or pharmacological approaches.

Budget and Timeline

• Estimated budget: $50,000 (participant recruitment, supplements, laboratory tests, and personnel).


• Study duration: 15 months (3 months for recruitment, 3 months intervention, 9 months data analysis and reporting).

Conclusion
This proposal aims to address a critical gap in cardiovascular health by evaluating a natural, evidence-based intervention. Psyllium husk’s accessibility and favorable safety profile position it as a promising candidate for improving lipid management and reducing CVD risk.