Healthy Unique Lipids From Almonds

NCT ID: NCT05782218

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-11-22

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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Almond arm

Almonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids.

Group Type: EXPERIMENTAL

Almonds

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.

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.

Group Type: EXPERIMENTAL

Coconut

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Almonds

Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Debedat, PharmD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Sean H Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

GH-22-DebedatJ-NR-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1950391

Identifier Type: -

Identifier Source: org_study_id