Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers

Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers: A Randomized Controlled Dietary Intervention Trial

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.

Study Overview

• Status: Terminated
• Conditions: Microbiota
• Intervention / Treatment: Other: Almonds; Other: Omelette

Detailed Description

Men and women with elevated waist circumference aged between 18-75 yrs will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized study; each treatment period will be 4 weeks in length, with a 4 week washout period separating each treatment. Participants will be randomized to consume either i) almonds, or ii) omelettes at 15% of energy. Each of the treatment products will contain equal levels of calories.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 6C5
      • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almonds	Other: Almonds; Almonds will be provided as 15% energy
Active Comparator: Omelette	Other: Omelette; Omelettes will be provided as 15% energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		4 weeks
Fecal short chain fatty acids		4 weeks
Waist circumference		4 weeks
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
Interleukin 1 beta		4 weeks
Interleukin 6		4 weeks
Tumor necrosis factor alpha		4 weeks
Serum amyloid A		4 weeks
C-reactive protein		4 weeks
Vascular cell adhesion molecule 1		4 weeks
Intercellular adhesion molecule 1		4 weeks
7α-hydroxy-4-cholesten-3-one		4 weeks
Fatty acid synthesis rate		4 weeks
Cholesterol synthesis rate		4 weeks
Cholesterol absorption rate		4 weeks
Body mass index	Weight and height will be combined to report BMI in kg/m^2	4 weeks
Hip circumference		4 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Almond Board of California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B2017:105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No