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Soy Pretzel for High Cholesterol

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University Medical Center, Columbus, OHHigh Cholesterol+1 MoreSoy Pretzel - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will investigate whether pretzels containing soy improve cholesterol levels and inflammation in HIV-infected individuals taking HIV medications.

Eligible Conditions
  • High Cholesterol
  • HIV/AIDS

Treatment Effectiveness

Effectiveness Progress

1 of 3

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3BNC117-LS and 10-1074-LS
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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 6 weeks or 28 weeks

28 weeks
Evidence of Improved Immunologic Function of Soy Pretzels in Antiretroviral Therapy-Treated HIV+ patients
Week 28
Self-Reported Daily Diary to Assess Adherence of Dietary Intervention
Serious and Non-Serious Adverse Events with Pretzel Intervention (Division of AIDS Adverse Event version 2.0)
Week 28
Evidence of Improved Arterial Function in Antiretroviral Therapy-Treated HIV+ Patients after Soy Pretzel Intervention
Evidence of Improved lipid parameters in Antiretroviral Therapy Treated HIV+ patients with soy pretzel intervention

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
3BNC117-LS
1
3BNC117-LS and 10-1074-LS
2
VIR-2482 (Dose 1)

Trial Design

3 Treatment Groups

Soy Pretzel
1 of 3
Soy Pretzel-Short Feasibility
1 of 3
Wheat Pretzel
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

100 Total Participants · 3 Treatment Groups

Primary Treatment: Soy Pretzel · Has Placebo Group · Phase 1 & 2

Soy Pretzel-Short Feasibility
Other
Experimental Group · 1 Intervention: Soy Pretzel · Intervention Types: Other
Wheat Pretzel
Other
PlaceboComparator Group · 1 Intervention: Wheat Pretzel · Intervention Types: Other
Soy Pretzel
Other
ActiveComparator Group · 1 Intervention: Soy Pretzel · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks or 28 weeks

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
728 Previous Clinical Trials
458,939 Total Patients Enrolled
1 Trials studying High Cholesterol
74 Patients Enrolled for High Cholesterol
Nicholas Funderburg, PhDPrincipal Investigator - Ohio State University
Ohio State University

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older, regardless of your gender.
References

Frequently Asked Questions

What is the sample size of this ongoing research?

"Affirmative. Perusing the details on clinicaltrials.gov unveils that this medical trial, first posted on June 1st 2016 is actively searching for participants. The research necessitates 100 subjects from a single site to be recruited." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this experiment open at the moment?

"Affirmative. Clinicaltrials.gov data shows that this research effort, first posted on June 1st 2016, is actively recruiting participants. Around 100 individuals need to be enrolled at a single medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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