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

NCT02818283 | Terminated

• 1 other identifier: 2015H0375
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Human Immunodeficiency Virus (HIV) Infection; Hypercholesterolemia

Keywords

Human Immunodeficiency Virus; hypercholesterolemia; pretzels; nutritional study; dietary soy; antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

• Serious and Non-Serious Adverse Events with Pretzel Intervention (Division of AIDS Adverse Event version 2.0)

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

  6 weeks or 28 weeks

• Self-Reported Daily Diary to Assess Adherence of Dietary Intervention

  Number of participants reporting 80% adherence to pretzels will have quantifiable levels of isoflavone (naturally occurring compounds in soy) metabolites in urine during soy pretzel intervention.

  6 weeks or 28 weeks

Secondary Outcomes (3)

• Evidence of Improved lipid parameters in Antiretroviral Therapy Treated HIV+ patients with soy pretzel intervention

  baseline to 6 weeks or baseline to 28 weeks

• Evidence of Improved Arterial Function in Antiretroviral Therapy-Treated HIV+ Patients after Soy Pretzel Intervention

  baseline to 6 weeks or baseline to 28 weeks

• Evidence of Improved Immunologic Function of Soy Pretzels in Antiretroviral Therapy-Treated HIV+ patients

  28 weeks

Study Arms (3)

Soy Pretzel-Short Feasibility

EXPERIMENTAL

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

Dietary Supplement: Soy Pretzel

Soy Pretzel

ACTIVE COMPARATOR

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.

Dietary Supplement: Soy Pretzel

Wheat Pretzel

PLACEBO COMPARATOR

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.

Other: Wheat Pretzel

Interventions

Soy Pretzel DIETARY_SUPPLEMENT

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).

Soy Pretzel; Soy Pretzel-Short Feasibility

Wheat Pretzel OTHER

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).

Wheat Pretzel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males aged 18 years or older.
• ACC/AHA 2013 Guidelines 10 year risk between \<15%
• HIV-1 infection as documented by any licensed ELISA (enzyme-linked immunosorbent assay) test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
• Receiving any stable Department of Health and Human Services (DHHS) recommended or alternative antiretroviral regimen for at least the last 12 weeks prior to study entry.
• Cumulative duration of antiretrovirals for at least 12 months at study entry.
• Documentation of at least 2 consecutive HIV-1 RNA levels of ≤50 copies/mL using any standard commercially assay for at least 6 months prior to study entry. An isolated (non-consecutive) HIV RNA \> 50 copies/mL (but less than 400 copies/mL) within the previous 12 months is permitted.
• Provides written informed consent and is capable of reading and comprehending the informed consent.
• Meet Karnofsky performance status ≥70.
• Have a body mass index (BMI) between 20-35 kg/m2.
• Have a fasting total cholesterol levels of ≥200mg/dL AND either LDL cholesterol level of 120 to 190mg/dL or a HDL ≤ 40 mg/dL
• Laboratory values obtained at screening:
• ANC (absolute neutrophil count) \>1000/mm3
• Hemoglobin \>11 g/dL
• Platelets ≥100,000/mm3
• Calculated creatinine clearance (CrCl) \>60 mL/min, as estimated by the Cockcroft-Gault equation

You may not qualify if:

• Need (or anticipated need in the next 24 weeks) for lipid modification pharmacotherapy or hypolipidemics (e.g., statins or fibrates) or hypoglycemic therapy.
• A clinically important illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
• Chronic hepatitis B or C infection Note: Participants who have been treated for their hepatitis C and have achieved a sustained virologic response (SVR) of 12 may participate.
• Any active or chronic uncontrolled inflammatory condition.
• Diarrhea or vomiting of Grade ≥ 2 within 14 days prior to study entry.
• An active AIDS-defining opportunistic infection or disease (for the purpose of this study, a cluster of differentiation 4 (CD4) count \<200 cells/mm3 in the absence of any other AIDS-defining indicator condition is not considered an AIDS-defining event).
• Inability to maintain adherence to study schedule or communicate with study personnel.
• Current alcohol or recreational drug use which in the investigator's opinion interferes with the subject's ability to comply with dosing schedule and protocol evaluations.
• Have had a full treatment course/regimen of antibiotics 6 months prior to start of study.
• Known sensitivity or allergy or intolerance to wheat, soy, or any of the ingredients found in pretzels (yeast, soy bean oil, palm oil, or diastase enzymes).
• Have had a malignancy of any kind or ongoing chemotherapy, radiation therapy, or other cancer-related treatment.
• Concurrent use of immunosuppressant medications, including but not limited to immunomodulating agents, steroids, and chronic anti-inflammatory agents.
• Active metabolic or digestive illness including malabsorptive disorders, diabetes mellitus (indicated by Hgb A1c of ≥6.8% or on exogenous insulin therapy), renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, or short bowel syndrome, have an active or a recent history of any condition that causes altered immunity, co-morbid cardiac, pulmonary, renal, neurologic, and endocrine.
• Known underlying myositis or muscle disease.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hypercholesterolemia

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicholas Funderburg, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)