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

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) Infection focused on measuring Human Immunodeficiency Virus, hypercholesterolemia, pretzels, nutritional study, dietary soy, antiretroviral therapy Read More

Inclusion Criteria:

• 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
  • ALT (alanine aminotransferase) <5 x ULN (upper limit of normal) or ALT <3 x ULN and total bilirubin <1.5 x ULN Note: If the potential subject is taking an atazanavir-containing regimen at the time of screening, total bilirubin ≤5 x ULN is acceptable.
  • Hgb A1c (Hemoglobin A1c) ≤6.5%
• Have no plans to alter antiretroviral therapy (including structured treatment interruptions), diet (beyond soy intervention) or exercise regimens during the course of the study.
• Agree to collect urine for 24 hours and have blood collected, at specified time points.
• Agree to abstain from use of herbal or dietary supplements during the 6 weeks for the short-term study or 28 weeks for the placebo-controlled study or any other supplements that might interact with dietary soy intervention.
• Agree to follow a daily vitamin and mineral supplement regimen for 6 weeks for the short-term study or 28 weeks for the placebo-controlled study.
• Agree to abstain from legume foods or products made from these ingredients which are known to be high in isoflavones for 6 weeks or 28 weeks:

Soy: Edamame, Miso, Soy cheese, Tofu, Tempeh, Protein bars, Soymilk, Natto, Soy meat substitutes Beans: Navy, Kidney, Green beans, Lima, Pinto, Black beans, Cannellini, and Chickpeas Peas: Green, Snow, Black-eyed Peanuts: Peanuts, Peanut butter (1 tablespoon/week permitted) Sprouts: Alfalfa, Clover, Mung bean, Soybean

Exclusion Criteria:

• 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.
• Any change in the last 24 weeks in therapy with prescription omega-3 fatty acids (>2 gram/day of Lovaza®), fibrates, or prescription niacin. Therapy with OTC (over the counter) omega 3 fatty acids or with ≤ 2 g Lovaza® is allowed. Any statin therapy for longer than 14 days received in the last 24 weeks is exclusionary.
• 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.
• Lack of regular access to a household freezer (for pretzel storage).