Status:
TERMINATED
Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Almond Board of California
Conditions:
Microbiota
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03327441
Start Date
February 1 2018
End Date
August 31 2019
Last Update
March 17 2023
Active Locations (1)
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1
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5