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Whey Protein Comparisons for Blood Lipid Effects

ConditionCholesterol
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-59
SponsorMedinutra LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cholesterol reading of 190 to 225 mg/dL

Age 21-59 years old

Disqualifiers

Uncontrolled diabetes

Hypothyroidism or other hormonal problems that have not stabilized

Any liver diseases being actively treated

Cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard whey

    Dietary supplement

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

  • Hydrolyzed whey

    Dietary supplement

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Standard wheyPlacebo comparator 1 intervention
Group B: Hydrolyzed wheyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum cholesterol

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

Time frame
6 weeks

Secondary outcomes

1

Other Blood Lipids

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

Time frame
6 weeks
2

Inflammation markers

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)

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medinutra LLC

Lead sponsor

Dairy Management Inc.

Collaborator

Source ClinicalTrials.gov
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