Cheese Consumption and Human Microvascular Function

NCT03376555 | Completed Phase 1 Results

• 2 other identifiers: STUDY4340129552
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Increased dairy intake is associated with improved measures of blood vessel health. Dairy cheese, however, is often high in sodium. Dietary sodium can impair blood vessel function. The researchers examine if and how natural cheese may protect against impairments in blood vessel function caused by sodium. For this study, participants complete four 8-day controlled feeding periods in which they eat cheese (6 oz/day) or no cheese during a low-sodium or high-sodium base-diet. The participants complete baseline experiments while on their normal personal diet and then repeat experiments at the end of each controlled feeding period. In some of our experiments, the researchers use a technique called "microdialysis" (MD). With MD, the researchers perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. The researchers also use a standard technique called "flow mediated dilation" (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.

Conditions

Microvascular Dysfunction

Keywords

Sodium; Hypertension; Blood Pressure; Cardiovascular Disease; Nitric Oxide; Skin; Dairy; Cheese; Oxidative Stress; Diet; Flow Mediated Vasodilation; Nitroglycerin; Superoxide; Microcirculation

Outcome Measures

Primary Outcomes (1)

• Microvascular Reactivity to Acetylcholine

  Skin blood flow is measured with laser Doppler flowmetry (flux units) and normalized to cutaneous vascular conductance by dividing by mean arterial pressure. Log molar increasing concentrations of acetylcholine are perfused and dose response curves are generated. Dose response curves were analyzed to determine the logEC50 (log Molar)

  1 hour

Secondary Outcomes (3)

• Systolic Blood Pressure

  8 days

• Diastolic Blood Pressure

  8 days

• Flow Mediated Dilation

  8 days

Study Arms (1)

Impact of Dairy and Sodium on Microvascular Health

EXPERIMENTAL

Cross over design with a baseline and 4 dietary interventions

Dietary Supplement: Low sodium no cheese; Dietary Supplement: Low sodium cheese; Dietary Supplement: High sodium no cheese; Dietary Supplement: High sodium cheese

Interventions

Low sodium no cheese DIETARY_SUPPLEMENT

Diet contains 1,500 mg sodium per day Diet does not contain dairy cheese 8 days

Impact of Dairy and Sodium on Microvascular Health

Low sodium cheese DIETARY_SUPPLEMENT

Diet contains 1,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days

Impact of Dairy and Sodium on Microvascular Health

High sodium no cheese DIETARY_SUPPLEMENT

Diet contains 5,500 mg sodium per day Diet does not contain dairy cheese 8 days

Impact of Dairy and Sodium on Microvascular Health

High sodium cheese DIETARY_SUPPLEMENT

Diet contains 5,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days

Impact of Dairy and Sodium on Microvascular Health

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seated systolic pressure 120-140 mmHg
• Seated diastolic pressure 70-90 mmHg.
• Normoglycemic (HbA1C \<5.7%)

You may not qualify if:

• Taking pharmacotherapy that alters peripheral vascular control
• Pregnancy
• Breastfeeding
• Females taking contraceptives (pills, patches, shots, etc.) or hormone replacement therapy
• Taking illicit and/or recreational drugs
• Use of nicotine containing-products (e.g. smoking, chewing tobacco, etc.)
• Known allergy to latex or investigative substances

Sponsors & Collaborators

• Lacy Alexander: lead
• National Dairy Council: collaborator

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• Alba BK, Stanhewicz AE, Dey P, Bruno RS, Kenney WL, Alexander LM. Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide. J Nutr. 2020 Jan 1;150(1):55-63. doi: 10.1093/jn/nxz205.

  PMID: 31504721 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Professor Lacy Alexander
• Organization: Penn State University

lma191@psu.edu

8148671781

Study Officials

• Lacy M Alexander, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator and Outcomes Assessor are masked according to treatment.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Kinesiology

Model Details: All subjects participate in 4 diets in randomized order. The diets differ in the amount of sodium and dairy cheese content. Each diet is consumed for 8 days. Minimum washout of 1 week between diets. Baseline experiment is conducted prior to first dietary intervention, and the experiment is repeated after each dietary intervention.

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: July 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)