Clinical trial NCT03327441: Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers
Official title: Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers: A Randomized Controlled Dietary Intervention Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Microbiota
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2017-10-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal microbiome
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood total cholesterol
timeFrame: 4 weeks
measure: Blood low-density lipoprotein cholesterol
timeFrame: 4 weeks
measure: Blood high-density lipoprotein cholesterol
timeFrame: 4 weeks
measure: Blood triglycerides
timeFrame: 4 weeks
measure: Interferon gamma
timeFrame: 4 weeks
measure: Interleukin 1 beta
timeFrame: 4 weeks
measure: Interleukin 6
timeFrame: 4 weeks
measure: Tumor necrosis factor alpha
timeFrame: 4 weeks
measure: Serum amyloid A
timeFrame: 4 weeks
measure: C-reactive protein
timeFrame: 4 weeks
measure: Vascular cell adhesion molecule 1
timeFrame: 4 weeks
measure: Intercellular adhesion molecule 1
timeFrame: 4 weeks
measure: 7α-hydroxy-4-cholesten-3-one
timeFrame: 4 weeks
measure: Fecal short chain fatty acids
timeFrame: 4 weeks
measure: Fatty acid synthesis rate
timeFrame: 4 weeks
measure: Cholesterol synthesis rate
timeFrame: 4 weeks
measure: Cholesterol absorption rate
timeFrame: 4 weeks
measure: Body mass index
timeFrame: 4 weeks
measure: Waist circumference
timeFrame: 4 weeks
measure: Hip circumference
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rotimi Aluko, PhD
role: PRINCIPAL_INVESTIGATOR
References: