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NCT02818283 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Ohio State University.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT02818283: Clinical Trial NA study, sponsored by Ohio State University.

NCT02818283 is a NA study that was terminated before completion, run by Ohio State University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02818283, a NA study, was terminated before completion, sponsored by Ohio State University.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

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.

Primary Outcome

Number of participants having adverse events with daily consumption of pretzels.

Interventions

  • DIETARY_SUPPLEMENT Soy Pretzel
  • OTHER Wheat Pretzel

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2016-06
Est. Completion 2023-10
Phase NA
Ohio State University

552 total trials

Why NCT02818283 stopped before completion

NCT02818283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Soy Pretzel is the first listed.

NCT02818283 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02818283 about?

NCT02818283 is a clinical study titled "Soy Modulation of Immune Activation, LDL- Levels, and Lowering Inflammation by Pretzel Isoflavone Dietary Intervention". 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 ...

What is the current status of trial NCT02818283?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2016-06. Estimated completion is 2023-10.

What interventions are being tested in trial NCT02818283?

The interventions under investigation include: Soy Pretzel (DIETARY_SUPPLEMENT), Wheat Pretzel (OTHER).

Who is sponsoring clinical trial NCT02818283?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02818283's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02818283, the US trial registry maintained by the National Library of Medicine. NCT02818283 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.