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

University of Manitoba

Status

Terminated

Conditions

Microbiota

Treatments

Other: Omelette

Other: Almonds

Study type

Interventional

Funder types

Other

Identifiers

NCT03327441

B2017:105

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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