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

NCT ID: NCT03327441

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-08-31

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.

Conditions

Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Almonds

Group Type: EXPERIMENTAL

Almonds

Intervention Type: OTHER

Almonds will be provided as 15% energy

Omelette

Group Type: ACTIVE_COMPARATOR

Omelette

Intervention Type: OTHER

Omelettes will be provided as 15% energy

Interventions

Almonds

Almonds will be provided as 15% energy

Intervention Type: OTHER

Omelette

Omelettes will be provided as 15% energy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rotimi Aluko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2017:105

Identifier Type: -

Identifier Source: org_study_id