Recruiting

Hydrolyzed Whey for Cholesterol Management in Adults

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What is being tested

Standard whey

+ Hydrolyzed whey
Dietary Supplement
Who is being recruted

From 21 to 59 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorMedinutra LLC
Study ContactRobert DiSilvestro, Ph.D.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 5, 2025Actual date on which the first participant was enrolled.

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 group have borderline high cholesterol and do not use medication to manage it. The aim is to see if a specific type of whey protein can help lower cholesterol levels directly, which could be a safe and cost-effective alternative to medications. This research might also show if hydrolyzed whey can reduce low-level inflammation, which is linked to several long-term health problems. Participants will consume either hydrolyzed whey protein or whey protein isolate daily for six weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which protein each participant is consuming. Blood samples will be taken before and after the six-week period to measure changes in cholesterol levels and inflammation markers. The study aims to determine if there is a significant change in these health markers, with safety considerations primarily focusing on potential allergies to whey protein. Participants with known milk allergies will not be eligible to join.

Official TitleHydrolyzed Whey for Blood Lipid Control 
NCT07101263
Principal SponsorMedinutra LLC
Study ContactRobert DiSilvestro, Ph.D.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
72 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 59 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: * Cholesterol reading of 190 to 225 mg/dL * Age 21-59 years old Exclusion Criteria: * Uncontrolled diabetes * Hypothyroidism or other hormonal problems that have not stabilized * Any liver diseases being actively treated * Cancer * Renal dialysis use * Rheumatoid arthritis and related issues like lupus * Inflammatory bowel disease * Smoking * Following a very restrictive diet * Low blood pressure * Statin drug use * Having more than 5 alcoholic drinks per week * Extreme obesity (BMI over 37) * Pregnancy or lactation * Allergies to milk protein * History of discomfort after consuming whey protein

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
A standard whey protein is consumed daily for 6 weeks

A typical whey protein is given that differs in chemical structure from the atypical whey protein used in the experimental group
Group II
Experimental
A hydrolyzed whey protein is consumed daily for 6 weeks

This type of whey has different chemical structure from typical wheys such as that used in this nstudy's control group
Study Objectives
Primary Objectives

Serum total and LDL cholesterol (mg/dL) will be assessed
Secondary Objectives

Serum HDL cholesterol and triglycerides (mg/dL) will be assessed, but mean values are not expected to change in either group

As a secondary consideration, this study will assess 3 blood measures relevant to low level inflammation: serum c reactive protein (mg/dL), serum alanine aminotransferase (ALT-Units/L), and whole blood glutathione (mg/L)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Medinutra LLCDublin, United StatesSee the location
Recruiting
One Study Center
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