NCT04223323

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

3.9 years

First QC Date

November 12, 2019

Last Update Submit

December 3, 2024

Conditions

Overweight and Obesity

Keywords

AlmondGastrointestinal microbiotaMetabolic healthBile acid profiles

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline & 12-week mark

  • 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.

    Baseline & 12-week mark

  • 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.

    Baseline & 12-week mark

  • 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.

    Baseline & 12-week mark

Secondary Outcomes (3)

  • Changes in liver fat

    Baseline & 12-week mark

  • Changes in glycemic control.

    Baseline & 12-week mark

  • Changes in secondary measures of gastrointestinal health.

    Baseline & 12-week mark

Other Outcomes (3)

  • Changes in markers of systemic inflammation & metabolism

    Baseline & 12-week mark

  • Changes in adiposity.

    Baseline & 12-week mark

  • Changes in subjective measures of gastrointestinal health.

    Baseline & 12-week mark

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Almonds

Isocaloric Control

PLACEBO COMPARATOR

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

Dietary Supplement: Pretzels

Interventions

AlmondsDIETARY_SUPPLEMENT

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

Intervention
PretzelsDIETARY_SUPPLEMENT

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

Isocaloric Control

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hannah D Holscher, PhD RD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

January 10, 2020

Study Start

February 10, 2020

Primary Completion

December 20, 2023

Study Completion

December 20, 2023

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)