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Soy Pretzel for High Cholesterol (SMALLLIPIDS Trial)
N/A
Waitlist Available
Led By Nicholas Funderburg, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks or 28 weeks
Awards & highlights
SMALLLIPIDS Trial 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
SMALLLIPIDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks or 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks or 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
Evidence of Improved Arterial Function in Antiretroviral Therapy-Treated HIV+ Patients after Soy Pretzel Intervention
Evidence of Improved Immunologic Function of Soy Pretzels in Antiretroviral Therapy-Treated HIV+ patients
Evidence of Improved lipid parameters in Antiretroviral Therapy Treated HIV+ patients with soy pretzel intervention
SMALLLIPIDS Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Soy Pretzel-Short FeasibilityExperimental Treatment1 Intervention
6 week intervention involving daily consumption of soy pretzel (two packets, 5 oz./packet) for 28 days. Participants will follow a legume-free diet which restricts the consumption of legume foods (soy, beans, peas, peanuts, and lentils) during the study period. This arm will precede the longer 28 week study
Group II: Soy PretzelActive Control1 Intervention
28 week intervention involving daily consumption of soy pretzel (two packets, 5 oz./packet) for 12 weeks. Participants will follow a legume-free diet which restricts the consumption of legume foods (soy, beans, peas, peanuts, and lentils) during the study period. Participants will be randomized to start with soy pretzel or wheat pretzel arm and crossover to the other pretzel at week 14.
Group III: Wheat PretzelPlacebo Group1 Intervention
28 week intervention involving daily consumption of wheat pretzel (two packets, 5 oz./packet) for 12 weeks. Participants will follow a legume-free diet which restricts the consumption of legume foods (soy, beans, peas, peanuts, and lentils) during the study period. Participants will be randomized to start with soy pretzel or wheat pretzel arm and crossover to the other pretzel at week 14.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,742 Total Patients Enrolled
1 Trials studying High Cholesterol
74 Patients Enrolled for High Cholesterol
Nicholas Funderburg, PhDPrincipal Investigator - Ohio State University
Ohio State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had moderate or severe diarrhea or vomiting in the past two weeks before joining the study.You have a known muscle disease or condition called myositis.You have a known sensitivity, allergy, or intolerance to wheat, soy, or any of the ingredients found in pretzels.Your weight is within a certain range based on your height.You need to avoid eating foods made from legumes, like beans and soy products, that contain high levels of isoflavones for either 6 or 28 weeks, depending on the study.You should avoid consuming soy-based foods like edamame, tofu, and soy milk, as well as beans like kidney beans and black beans, peas like green peas, and sprouts like alfalfa and mung bean sprouts. However, you can have a small amount of peanuts or peanut butter once a week.You have a medical condition with ongoing inflammation that is not well controlled.You currently have any type of cancer or are undergoing treatment for cancer.You have ongoing or recent health conditions that affect your metabolism, digestion, kidneys, liver, thyroid, or immune system. You also have other existing heart, lung, kidney, brain, or hormone-related conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Soy Pretzel-Short Feasibility
- Group 2: Wheat Pretzel
- Group 3: Soy Pretzel
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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