NCT03327441

Brief Summary

The overall goal is to assess the health benefits of almond consumption on gut microbiome patterns and their association with circulating disease risk biomarkers, as well as the processes that control those pathways. Health benefits will be assessed relative to a omelette control.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

October 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 17, 2023

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

October 23, 2017

Last Update Submit

March 16, 2023

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal microbiome

    Bacterial community alpha-diversity measured using richness and diversity indices including Chao1, Shannon, Inverse Simpson. Bacterial community beta-diversity measured using weighted and unweighted UniFrac distances. The most abundant Operational Taxonomic Units (OTUs) within the bacterial community identified based on the relative abundances of the OTUs within the community. Bacterial community composition at the phylum and genus levels described based on the relative abundances of each taxa within the community. Bacterial community functional capacity measured based on the relative abundances of collected predicted functions of the community members. Ecological relationships between members of bacterial community assessed using correlation network modelling to identify keystone and foundation members of the bacterial community that have the highest number of positive (supportive) or negative (suppressive) connections (\>15) with other members of community.

    4 weeks

Secondary Outcomes (21)

  • Blood total cholesterol

    4 weeks

  • Blood low-density lipoprotein cholesterol

    4 weeks

  • Blood high-density lipoprotein cholesterol

    4 weeks

  • Blood triglycerides

    4 weeks

  • Interferon gamma

    4 weeks

  • +16 more secondary outcomes

Study Arms (2)

Almonds

EXPERIMENTAL
Other: Almonds

Omelette

ACTIVE COMPARATOR
Other: Omelette

Interventions

AlmondsOTHER

Almonds will be provided as 15% energy

Almonds
OmeletteOTHER

Omelettes will be provided as 15% energy

Omelette

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give written informed consent
  • Men and women 18-75 yr
  • Elevated waist circumferences (women greater than or equal to 80 cm, men greater than or equal to 94 cm)
  • LDL-C greater than or equal to 2.8 mmol/L, or less than or equal to 4.9 mmol/L
  • Non-smokers
  • Possess a telephone or email address to enable regular contact
  • Able to read, write and speak English

You may not qualify if:

  • Pregnant female, or planning to become pregnant during the study period
  • Weight gain or loss of at least 10lbs in previous three months
  • Allergic to almonds, eggs, milk
  • Exercising \> 15 miles/wk or 4,000 kcal/wk
  • Those currently taking (or have taken within the past 3 months) lipid-lowering medications (i.e., statins)
  • Those currently taking (or have taken within the last 3 months) lipid-lowering supplements (i.e., omega-3 supplements, plant sterols/stanol foods and/or supplements, fibre, etc.)
  • Those currently taking (or have taken within the last 3 months) probiotic supplements and foods containing added probiotics (i.e., kefir, Activia, Kashi: Vive Probiotic Digestive Wellness Cereal)
  • Previous history of diabetes, hypertension, gastrointestinal disease, liver or lung disease or cancer, hyperthyroidism or hypothyroidism, or lung disease.
  • Alcohol use of \>2 drinks/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

MeSH Terms

Interventions

Rab1 protein, Drosophila

Study Officials

  • Rotimi Aluko, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 31, 2017

Study Start

February 1, 2018

Primary Completion

April 30, 2019

Study Completion

August 31, 2019

Last Updated

March 17, 2023

Record last verified: 2021-04

Locations

CA(1)