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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almonds
Pretzels
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Almond, Gastrointestinal microbiota, Metabolic health, Bile acid profiles

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Isocaloric Control

Arm Description

The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks.

The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks.

Outcomes

Primary Outcome Measures

Changes in gastrointestinal microbiota composition
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.
Changes in abundance of fecal Roseburia spp
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
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.
Changes in gastrointestinal microbial-derived metabolite concentrations
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.

Secondary Outcome Measures

Changes in liver fat
Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.
Changes in glycemic control.
Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.
Changes in secondary measures of gastrointestinal health.
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.

Full Information

First Posted
November 12, 2019
Last Updated
April 26, 2022
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT04223323
Brief Title
Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health
Acronym
SNACKing
Official Title
SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Almond Board of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Almond, Gastrointestinal microbiota, Metabolic health, Bile acid profiles

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks.
Arm Title
Isocaloric Control
Arm Type
Placebo Comparator
Arm Description
The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Almonds
Intervention Description
Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pretzels
Intervention Description
Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.
Primary Outcome Measure Information:
Title
Changes in gastrointestinal microbiota composition
Description
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.
Time Frame
Baseline & 12-week mark
Title
Changes in abundance of fecal Roseburia spp
Description
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Time Frame
Baseline & 12-week mark
Title
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
Description
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.
Time Frame
Baseline & 12-week mark
Title
Changes in gastrointestinal microbial-derived metabolite concentrations
Description
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.
Time Frame
Baseline & 12-week mark
Secondary Outcome Measure Information:
Title
Changes in liver fat
Description
Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.
Time Frame
Baseline & 12-week mark
Title
Changes in glycemic control.
Description
Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.
Time Frame
Baseline & 12-week mark
Title
Changes in secondary measures of gastrointestinal health.
Description
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.
Time Frame
Baseline & 12-week mark
Other Pre-specified Outcome Measures:
Title
Changes in markers of systemic inflammation & metabolism
Description
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).
Time Frame
Baseline & 12-week mark
Title
Changes in adiposity.
Description
Determine the impact of daily consumption of almonds on adiposity compared to control (pretzels) using a DXA scan.
Time Frame
Baseline & 12-week mark
Title
Changes in subjective measures of gastrointestinal health.
Description
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.
Time Frame
Baseline & 12-week mark

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah D Holscher, PhD RD
Phone
217-300-2512
Email
hholsche@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ginger Reeser, MS RD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah D Holscher, PhD RD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ginger Reeser, MS, RDN, LDN
Phone
217-244-8442
Email
reeser2@illinois.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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