Healthy Unique Lipids From Almonds

NCT05782218 | Completed

• 2 other identifiers: 1950391GH-22-DebedatJ-NR-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

microbiome; cyclopropane; nutrition; unsaturated; fatty acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiome features associated with post-meal metabolite patterns

  One day (during the feeding day)

Other Outcomes (1)

• Relationship between dietary habits and baseline (pre-meal) microbiota-derived blood metabolite levels in the baseline blood.

  One day (inclusion visit)

Study Arms (2)

Almond arm

EXPERIMENTAL

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

Dietary Supplement: Almonds

Coconut arm

EXPERIMENTAL

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

Interventions

Almonds DIETARY_SUPPLEMENT

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

Almond arm

Coconut 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.

Coconut arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Almond Board of California: collaborator

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Study Officials

• Jean Debedat, PharmD/PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Sean H Adams, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 23, 2023
• Study Start: March 31, 2023
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)