NCT05782218已完成不适用
HULA Study - Healthy Unique Lipids From Almonds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the level of microbe-derived metabolites
研究概览
简要总结
This project will address the notion that "healthy" lipids such as monounsaturated fatty acids in almonds can be used by the bacteria living in our gut to generate "new" molecules with potentially interesting health properties. This metabolite pattern is anticipated to differ significantly when compared to non-almond foods rich in saturated fats.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •18 to 50 years of age
- •Body mass index (BMI) categorized "normal" through "overweight" (18.5 - 29.9 kg/m2)
- •Able to provide informed consent in English
排除标准
- •pregnancy or lactation
- •allergy or aversion to any of the foods that will be studied and/or provided
- •history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
- •history of metabolic diseases (type 2 diabetes, hyperlipidemia)
- •previous gastrointestinal resection or bariatric surgery
- •bleeding disorders that preclude blood draws
- •recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy that is not medically stable
- •cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
- •regular alcohol intake of > 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits) and unwilling to abstain during the run-in week and test day
- •use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc.) and not willing to abstain during the run-in week and test day
- •use of illicit drugs and not willing to abstain during the run-in week and test day
- •BMI ≥30 kg/m2
- •regular (daily to weekly) use of over the counter (OTC) weight-loss aids, anti-acids or anti-inflammatories, and unwilling or unable to stop taking during the run-in week and test day
- •regular OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: fiber, fish oil (including cod liver oil), probiotics, and unwilling or unable to stop taking during the run-in week and test day
- •oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
- •seated blood pressure >140/90 mmHg
- •fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw (Glucose (fasting), Urea, Creatinine, eGFR, Sodium, ALT/GPT, AST/GOT, Alk Phos, Total Bilirubin, Total protein, Albumin, Complete blood count, hematocrit, Total Cholesterol, HDL/LDL cholesterol, Triglycerides, Insulin Free, Total Insulin, Hemoglobin A1C)
- •current use of specific prescription medication(s): Coumadin, Opiates within 1 month of study, Chlorthalidone, Canagliflozin, Tetracycline, Heparin, Anti-psychotics, Chlorothiazide, Dapagliflozin, Cephalosporin, Eliquis, Lithium, Hydrochlorothiazide, Empagliflozin, Penicillin, Indapamide, Insulin, Quinolone, Metolazone, Acarbose, Lincomycin, Oral Steroids within 1 month of study, Cholestyramine, Amiloride hydrochloride, Miglitol, Macrolide, RA / psoriasis medications, Colesevelam, Spironolactone, Liraglutide, Sulfonamide, Medications for rheumatologic / hematologic active disease, Colestipol, Triamterene, Metformin, Glycopeptide Abs, Ezetimibe, Furosemide, Aminoglycosides, Fenofibrate, Bumetanide, HIV/HAART therapy, Statins, Proton-pump inhibitors
- •inability to freely give informed consent in English
结局指标
主要结局
Change in the level of microbe-derived metabolites
时间窗: One day (during the feeding day)
Changes in the concentrations of microbe-derived metabolites in the blood and/or urine and/or stool of participants in the almond arm, versus a significantly different profile in participants in the coconut arm.
次要结局
- Microbiome features associated with post-meal metabolite patterns(One day (during the feeding day))
研究者
研究点 (2)
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