Clinical trial NCT05782218: Healthy Unique Lipids From Almonds
Official title: HULA Study - Healthy Unique Lipids From Almonds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Keywords: microbiome
cyclopropane
nutrition
unsaturated
fatty acids
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2023-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the level of microbe-derived metabolites
timeFrame: One day (during the feeding day)
Secondary outcomes:
measure: Microbiome features associated with post-meal metabolite patterns
timeFrame: One day (during the feeding day)
Other outcomes:
measure: Relationship between dietary habits and baseline (pre-meal) microbiota-derived blood metabolite levels in the baseline blood.
timeFrame: One day (inclusion visit)
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Jean Debedat, PharmD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Sean H Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: