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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Microbiota

Intervention / Treatment
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* Other: Almonds
* Other: Omelette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almonds<br> | Other: Almonds<br>* Almonds will be provided as 15% energy<br>|
| Active Comparator: Omelette<br> | Other: Omelette<br>* Omelettes will be provided as 15% energy<br>|

What is the study measuring?
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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 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 | 
| Fecal short chain fatty acids |  | 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 | 
| Waist circumference |  | 4 weeks | 
| Hip circumference |  | 4 weeks | 
| Blood pressure |  | 4 weeks |