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

NCT ID: NCT04223323

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2023-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Overweight and Obesity

Keywords

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Almond Gastrointestinal microbiota Metabolic health Bile acid profiles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Almonds

Intervention Type DIETARY_SUPPLEMENT

Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.

Isocaloric Control

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

Group Type PLACEBO_COMPARATOR

Pretzels

Intervention Type DIETARY_SUPPLEMENT

Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.

Interventions

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Almonds

Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Pretzels

Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almond Board of California

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah D Holscher, PhD RD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

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University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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20154

Identifier Type: -

Identifier Source: org_study_id