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

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03327441
• Other study ID #: B2017:105
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: August 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

Other:
• Almonds
Almonds will be provided as 15% energy
• Omelette
Omelettes will be provided as 15% energy

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Almond Board of California

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood total cholesterol		4 weeks
Secondary	Blood low-density lipoprotein cholesterol		4 weeks
Secondary	Blood high-density lipoprotein cholesterol		4 weeks
Secondary	Blood triglycerides		4 weeks
Secondary	Interferon gamma		4 weeks
Secondary	Interleukin 1 beta		4 weeks
Secondary	Interleukin 6		4 weeks
Secondary	Tumor necrosis factor alpha		4 weeks
Secondary	Serum amyloid A		4 weeks
Secondary	C-reactive protein		4 weeks
Secondary	Vascular cell adhesion molecule 1		4 weeks
Secondary	Intercellular adhesion molecule 1		4 weeks
Secondary	7a-hydroxy-4-cholesten-3-one		4 weeks
Secondary	Fecal short chain fatty acids		4 weeks
Secondary	Fatty acid synthesis rate		4 weeks
Secondary	Cholesterol synthesis rate		4 weeks
Secondary	Cholesterol absorption rate		4 weeks
Secondary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	4 weeks
Secondary	Waist circumference		4 weeks
Secondary	Hip circumference		4 weeks
Secondary	Blood pressure		4 weeks