Healthy Unique Lipids From Almonds (HULA)

HULA Study - Healthy Unique Lipids From Almonds

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: Almonds; Dietary supplement: Coconut

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almond arm; Almonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids.	Dietary supplement: Almonds; Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.
Experimental: Coconut arm; 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; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between dietary habits and baseline (pre-meal) microbiota-derived blood metabolite levels in the baseline blood.	Positive or negative statistical associations between dietary habits and baseline circulating levels of microbial metabolites.	One day (inclusion visit)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Almond Board of California
• Investigators: Principal Investigator: Sean H Adams, PhD, University of California, Davis; Principal Investigator: Jean Debedat, PharmD/PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: nutrition; microbiome; fatty acids; cyclopropane; unsaturated
• Other Study ID Numbers: 1950391; GH-22-DebedatJ-NR-01 (Other Grant/Funding Number: Almond Board of California)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No