Healthy Unique Lipids From Almonds

Study Overview
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Brief Summary
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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.

Official Title
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HULA Study - Healthy Unique Lipids From Almonds

Conditions
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Nutrition, Healthy

Intervention / Treatment
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* Dietary Supplement: Almonds
* Dietary Supplement: Coconut


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond arm<br>Almonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids. | Dietary Supplement: Almonds<br>* Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.<br>|
| Experimental: Coconut arm<br>This snack is isocaloric and almost perfectly matches the macronutrient profile of the almonds. However, despite being in the same quantity, almost all provided fatty acids will be saturated fatty acids. | Dietary Supplement: Coconut<br>* Participants will receive 1 oz (30 g) of a coconut-chocolate bar and 1.4 oz (40 g) of 100% dried coconut chips to ingest within 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the level of microbe-derived metabolites | 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. | One day (during the feeding day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome features associated with post-meal metabolite patterns | Positive or negative statistical associations between features in participants' gut microbiome and their post-meal changes in blood and/or urine and/or stool metabolites. | One day (during the feeding day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, cyclopropane, nutrition, unsaturated, fatty acids