NCT07101263

Brief Summary

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, a few blood measures will be taken that are relevant to low level inflammation. The main questions the study aims to answer are:

  • Will hydrolyzed whey lower serum cholesterol readings in adults with starting values in the upper end of normal to the lower end of elevated?
  • Will the hydrolyzed whey affect a general measure of inflammation and two measures of indirect relevance to inflammation? Researchers will compare hydrolyzed whey to a conventional whey (a control protein not expected to affect serum cholesterol readings) to see if the hydrolyzed whey lowers serum cholesterol. Participants will:
  • Drink one protein beverage every day for 6 weeks;
  • Go to a LabCorp facility for a blood draw before and after the 6 weeks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

July 28, 2025

Last Update Submit

August 5, 2025

Conditions

Cholesterol

Keywords

CholesterolWheyinflammationModerately elevated cholesterolHigh end normal cholesterol

Outcome Measures

Primary Outcomes (1)

  • Serum cholesterol

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

    6 weeks

Secondary Outcomes (2)

  • Other Blood Lipids

    6 weeks

  • Inflammation markers

    6 weeks

Study Arms (2)

Standard whey

PLACEBO COMPARATOR

A standard whey protein is consumed daily for 6 weeks

Dietary Supplement: Standard whey

Hydrolyzed whey

EXPERIMENTAL

A hydrolyzed whey protein is consumed daily for 6 weeks

Dietary Supplement: Hydrolyzed whey

Interventions

Standard wheyDIETARY_SUPPLEMENT

A typical whey protein is given that differs in chemical structure from the atypical whey protein used in the experimental group

Standard whey
Hydrolyzed wheyDIETARY_SUPPLEMENT

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

Hydrolyzed whey

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cholesterol reading of 190 to 225 mg/dL
  • Age 21-59 years old

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medinutra LLC

Dublin, Ohio, 43016, United States

RECRUITING

Related Publications (1)

  • Pins JJ, Keenan JM. Effects of whey peptides on cardiovascular disease risk factors. J Clin Hypertens (Greenwich). 2006 Nov;8(11):775-82.

    PMID: 17086017RESULT

Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Robert DiSilvestro, Ph.D.

CONTACT

614=348-9375nutritionstudy111@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 3, 2025

Study Start

August 5, 2025

Primary Completion

December 23, 2025

Study Completion

January 15, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)