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Soy Modulation of Immune Activation, LDL- Levels, and Lowering Inflammation by Pretzel Isoflavone Dietary Intervention

NCT02818283 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-10-06

No results posted yet for this study

Summary

Combination antiretroviral therapy (ART, HIV medications) dramatically increases the expected lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this population. This increased risk may be linked to persistent inflammation and activation of the immune system. Although the relationship between cardiovascular disease and HIV-infected individuals who are taking HIV medications is not well understood, the team of researchers involved in this study observed that a diet rich in soy, at levels recommended by the FDA (Federal Drug Administration), improved cholesterol levels and inflammation in individuals not infected with HIV. From this study, the researchers hope to gain understanding on how dietary soy will impact HIV-infected individuals who are taking HIV medications. Two pretzels with and without soy developed at OSU (Ohio State University) in the Department of Food Science and Technology and used in previous clinical trials will be used to investigate how the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your body breaks down naturally occurring chemicals from soy.

Conditions

Interventions

DIETARY_SUPPLEMENT

Soy Pretzel

Each packet (5oz.) of soy pretzel contains high gluten wheat flour, soy flour, soymilk, vegetable shortening, sugar, yeast, salt, and ascorbic acid. Each packet provides \~280 calories (16% fat, 54% total carbohydrates, and 30% protein).

OTHER

Wheat Pretzel

Each packet (5oz.) of wheat pretzel contains high gluten wheat flour, vital wheat gluten, shortening, sugar, yeast, salt, and ascorbic acid. Each packet provides \~290 calories (16% fat, 54% total carbohydrates, and 30% protein).

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Nicholas Funderburg, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818283 on ClinicalTrials.gov