Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health (SNACKing)

April 26, 2022 updated by: University of Illinois at Urbana-Champaign

SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism

The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ginger Reeser, MS RD

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana-Champaign
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males & Females
  • 30-60 years of age
  • BMI 25-34.9 kg/m^2
  • Ability to drop off fecal sample within 15 minutes of defecation

Exclusion Criteria:

  • Physician diagnosed metabolic or gastrointestinal diseases
  • Fasting blood glucose >126 mg/dL
  • Blood pressure >160/100 mm Hg
  • Anemia
  • Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
  • Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
  • Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function.
  • Pregnant, breastfeeding or postmenopausal
  • Smoker, tobacco use
  • Allergic to nuts
  • Consume > 2 alcoholic beverages/day
  • Abuse drugs
  • Have had > 5% weight change in the past month or > 10% change in the past year
  • Have taken antibiotics during the previous 2 months
  • Unable to consume the experimental treatments (almonds or pretzels)
  • Bariatric surgery
  • Gallbladder removal
  • Allergic to lidocaine or other topical anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks.
Dietary supplement: Almonds
Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.
Placebo Comparator: Isocaloric Control
The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks.
Dietary supplement: Pretzels
Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gastrointestinal microbiota composition
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Baseline & 12-week mark
Changes in abundance of fecal Roseburia spp
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Baseline & 12-week mark
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.
Baseline & 12-week mark
Changes in gastrointestinal microbial-derived metabolite concentrations
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.
Baseline & 12-week mark

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in liver fat
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.
Baseline & 12-week mark
Changes in glycemic control.
Time Frame: Baseline & 12-week mark
Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.
Baseline & 12-week mark
Changes in secondary measures of gastrointestinal health.
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on gastrointestinal health compared to control (pretzels) by measuring fecal pH; other microbial fermentation end products and microbial-derived bile acids using gas-liquid chromatography; and alpha- and beta- diversity measures of the gut microbiota community structure using 16S microbiota analyses.
Baseline & 12-week mark

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in markers of systemic inflammation & metabolism
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on inflammation and metabolism compared to control (pretzels) by measuring biomarker concentrations with ELISA. Specifically, we will look at TNF, CRP, & LPS-BP (inflammatory) and NEFAs (metabolism).
Baseline & 12-week mark
Changes in adiposity.
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on adiposity compared to control (pretzels) using a DXA scan.
Baseline & 12-week mark
Changes in subjective measures of gastrointestinal health.
Time Frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on subjective measures of gut health compared to control (pretzels) using stool records. The questionnaire addresses questions related to gastrointestinal health including bloating, flatulence, and stool consistency.
Baseline & 12-week mark

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: Hannah D Holscher, PhD RD, University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20154

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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