Hydrolyzed Whey for High Cholesterol

Overseen By Robert DiSilvestro, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medinutra LLC

Must not be taking: Statins

Disqualifiers: Diabetes, Cancer, Rheumatoid arthritis, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hydrolyzed whey protein can help maintain normal cholesterol levels in adults with slightly elevated cholesterol. Researchers will compare this special whey protein to regular whey to assess its effectiveness. Participants will consume a protein shake daily for six weeks and undergo blood tests before and after the trial to measure cholesterol and inflammation, which is the body's response to injury or illness. Individuals with cholesterol levels between 190 to 225 mg/dL and no major health issues, such as diabetes or liver disease, may be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could inform new dietary recommendations for managing cholesterol.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using statin drugs.

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

Research shows that hydrolyzed whey protein is usually easy to digest. Studies suggest it can safely improve certain health measures, such as blood pressure, in some adults. Importantly, major reports of harmful side effects with hydrolyzed whey have not emerged. However, protein powders can sometimes contain added sugars or other ingredients that might not suit everyone. Always check labels if concerned. Overall, based on current research, hydrolyzed whey appears to be a safe choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional cholesterol treatments that often rely on medications like statins, hydrolyzed whey offers a more natural approach. Researchers are excited about hydrolyzed whey because it is derived from a protein that is broken down into smaller, more easily absorbed peptides, which could enhance its cholesterol-lowering effects. This treatment is unique because it may provide a dietary alternative with fewer side effects, offering a promising option for those who prefer to avoid pharmaceuticals.

What evidence suggests that hydrolyzed whey might be an effective treatment for high cholesterol?

Research has shown that hydrolyzed whey protein, which participants in this trial may receive, might help lower cholesterol. A review of several studies found that whey protein could reduce LDL cholesterol, often known as "bad" cholesterol. Another review noted whey protein's positive effect on various fat levels in the blood. Although one study, later retracted, suggested hydrolyzed whey could lower both total and LDL cholesterol in people with certain blood pressure issues, these findings still suggest that hydrolyzed whey might help manage cholesterol levels. Participants in this trial will receive either hydrolyzed whey or standard whey to compare their effects on cholesterol. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with high cholesterol, specifically those at the upper end of normal to lower elevated levels. Participants will drink a protein beverage daily and visit LabCorp for blood tests before and after a 6-week period.

Inclusion Criteria

I am between 21 and 59 years old.

Cholesterol reading of 190 to 225 mg/dL

Exclusion Criteria

Following a very restrictive diet

I have cancer.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants consume either hydrolyzed whey or standard whey protein daily for 6 weeks

6 weeks

2 visits (in-person) for blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hydrolyzed whey
• Standard whey

Trial Overview The study is testing whether hydrolyzed whey protein can help maintain normal serum cholesterol compared to standard whey. It also examines if hydrolyzed whey impacts general inflammation measures.

How Is the Trial Designed?

Group I: Hydrolyzed whey Experimental Treatment 1 Intervention

A hydrolyzed whey protein is consumed daily for 6 weeks

Group II: Standard whey Placebo Group 1 Intervention

A standard whey protein is consumed daily for 6 weeks

Who Is Running the Clinical Trial?

Medinutra LLC

Lead Sponsor

Dairy Management Inc.

Industry Sponsor

Trials

21

Recruited

2,600+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424004448

The effects of whey protein supplementation on indices ... This meta-analysis included 21 RCTs. Whey protein supplementation had no effect on HDL-cholesterol concentration but did elicit a reduction in LDL-cholesterol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7504833/

Effects of whey protein on glycemic control and serum ... This meta-analysis suggests that supplementation with whey protein had beneficial effect on several indicators of glycemic control and lipid parameters

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07101263

Whey Protein Comparisons for Blood Lipid Effects In addition, a retracted study has shown that in people with pre-hypertension or moderate hypertension, hydrolyzed whey can reduce total and LDL cholesterol ...

4. patlynk.com patlynk.com/trial/NCT07101263

Hydrolyzed Whey for Cholesterol Management in Adults This study explores the potential benefits of hydrolyzed whey protein for managing cholesterol levels in adults aged 21 to 59. Many people within this age ...

5. withpower.com withpower.com/trial/phase-cholesterol-7-2025-a5352

Hydrolyzed Whey for High Cholesterol The goal of this clinical trial is to learn if hydrolyzed whey protein can help serum cholesterol stay in normal range in adults. As a side inquiry, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109393/

Retracted: Effects of Whey Peptides on Cardiovascular ... Hydrolyzed whey peptides appear to be a well tolerated and safe lifestyle option for improving BP in a population of prehypertensive or stage 1 hypertensive men ...

7. health.harvard.edu health.harvard.edu/staying-healthy/the-hidden-dangers-of-protein-powders

The hidden dangers of protein powders - Harvard Health The hidden dangers of protein powders. They may contain added sugar, calories, or even toxic chemicals.