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Cheese Consumption and Human Microvascular Function

L

Lacy Alexander

Status and phase

Completed
Phase 2
Phase 1

Conditions

Microvascular Dysfunction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03376555
STUDY4340
129552 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Subject screening will be performed by the Penn State Clinical Translational Research Center (CTRC) medical staff and will include a physical exam by a clinician, anthropometry, and a chemical and lipid profile, liver and renal function. Participants meet with a registered dietitian to determine their caloric energy requirements and identify food preferences. The interview includes surveying the subject's physical activity over the previous 7 days.

Subjects will undergo baseline microdialysis experiments to examine the function of the blood vessels in the skin microcirculation. Subjects will also go through a baseline assessment of conduit vessel endothelial and vascular smooth muscle function with brachial artery flow-mediated vasodilation (FMD), and sublingual nitroglycerin. Following baseline experiments, subjects participate in 4 controlled feeding periods, each 8 days in duration. The controlled feeding periods are assigned in a randomized order. At the end of each 8-day controlled dietary period, subjects will repeat microdialysis experiments, brachial artery FMD, and responsiveness to sublingual nitroglycerin.

Enrollment

13 patients

Sex

All

Ages

55 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Impact of Dairy and Sodium on Microvascular Health
Experimental group
Description:
Cross over design with a baseline and 4 dietary interventions
Treatment:
Dietary Supplement: High sodium cheese
Dietary Supplement: Low sodium cheese
Dietary Supplement: High sodium no cheese
Dietary Supplement: Low sodium no cheese

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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