Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials

May 5, 2021 updated by: Rudy Ortiz, University of California, Merced

Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials: Implications of Systemic Glucoregulatory Mechanisms

The purpose of the study is to examine the effects of almond snacking on metabolic, cardiovascular and microbiome profiles in college freshmen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nut (principally almond) consumption helps ameliorate cardiovascular disease, reduce the risk of type II diabetes mellitus (T2DM). Recent studies have demonstrated improvements in glycemic control in T2DM and impaired glucose tolerant (IGT) subjects as well as in healthy adults. The association between nut consumption and diabetes prevalence is largely mediated by changes in body mass (adiposity). The application of metabolomic and lipidomic approaches to better asses the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed.

Additionally, the gut microbiota has been proposed to contribute to a number of metabolic disorders including insulin sensitivity, glucose metabolism, and other cardiometabolic risk factors. However, data demonstrating the complex interactions among dietary interventions, gut microbiome, glucose regulation, and cardiovascular phenotype are lacking.

Furthermore, because all the studies on nut consumption and health have been performed on adults (median age of subjects: +40 years) and given the increasing incidence of metabolic disorders (obesity, insulin resistance, etc.) at much younger stages of life especially in the Central Valley of California, no data exist on the potential benefits of almonds in ameliorating metabolic disorders at a much earlier life stage. This may be clinically more important than studies in adults because the transition from adolescence to adulthood is associated with a number of potential risk factors unique to this age group, especially in those that enter their first year of college. The fixed age of the participants contributes to a more homogeneous population than has been previously studied, which greatly minimizes the potential for age-dependent alterations in physiology to either potentiate or mask the effects of the almonds on metabolic mechanisms. The nutritional independence that is associated with going away to college poses many potential health challenges, for example the phenomenon, "Freshman 15". The increased prevalence of overweight and obesity is greatest in 18-29 year olds, especially among those reporting some college education (10.6%-17.8% vs 7.1%-12.1% in 18-29 year olds overall) suggesting that some aspect of the collegiate experience is associated with weight gain.

While almond-supplemented diets have been shown to reduce body mass or ameliorate weight gain, the evidence substantiating the benefits of functional foods in addressing the weight gain commonly associated with the transition to college is scarce and an untapped area of research. Furthermore, this transition to nutritional independence makes new college students vulnerable to additional alterations in eating patterns. Among these concerns are the relatively high number of college freshmen that reported skipping breakfast (20%-43%), which is by far the most skipped meal among those studies reviewed. This is important because chronically skipping breakfast in adolescents has detrimental outcomes on cardiometabolic health and has negative impacts on academic performance. Additionally, most college students snack, with snacking common both in the morning and the afternoon. Data suggest a benefit to snacking on peanuts and almonds. However, the benefits of snacking in young college students who routinely skip a meal (breakfast here) are not defined. Therefore, being able to demonstrate the benefits of almonds in college "breakfast skippers" would have significant implications for young adults in their first year of college, and thus, provide an ideal opportunity to further address this line of inquiry. Lastly, the application of metabolomic and lipidomic approaches to better assess the mechanisms regulating carbohydrates and lipids in an almond-based study has not been performed. Advancements in high-throughput analytical techniques have initiated a renaissance in the study of metabolism on a grand scale that allow for robust assessment of nutritional status and cellular responses. These approaches provide an advantage of mapping metabolites in such a fashion that changes in mechanisms can be elucidated as demonstrated by the SuGAR Project.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Merced, California, United States, 95343
        • University of California, Merced

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria:

    • 18-22 years of age
    • Newly enrolled, 1st-year college students at University of California, Merced
    • Willing to eat almonds and study snacks
    • Willing to comply with the study protocol
    • Consistent diet and activity patterns
    • Non-smoker >1 year or more

  • Exclusion Criteria:

    • Nut allergies
    • Illicit drug use
    • Medications that affect metabolism or appetite
    • Anti-inflammatory medications, analgesics and antibiotics
    • Diabetes or pre-diabetes, uncontrolled hypertension, cardiovascular disease or dyslipidemia requiring drug therapy
    • Gastrointestinal disease and/or bariatric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almond group
2 oz. of almonds everyday for 8 weeks
Dietary supplement: Almonds
Active Comparator: Control group
Isoenergetic control group 5 graham cracker sheets everyday for 8 weeks
Dietary supplement: Graham crackers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fasting blood glucose
Time Frame: Change from baseline at 8 weeks
Change from baseline at 8 weeks
2-hour oral glucose tolerance test
Time Frame: At the end of 8 week intervention
At the end of 8 week intervention
Change in fasting blood insulin
Time Frame: Change from baseline at 8 weeks
Change from baseline at 8 weeks
Change in stool microbiome profiles
Time Frame: Change from baseline at 8 weeks
Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Every 2 weeks over the 8 week intervention
Every 2 weeks over the 8 week intervention
Body composition
Time Frame: Every 2 weeks over the 8 week intervention
Every 2 weeks over the 8 week intervention
Waist circumference
Time Frame: Every 2 weeks over the 8 week intervention
Every 2 weeks over the 8 week intervention
Blood pressure
Time Frame: Every 2 weeks over the 8 week intervention
Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Time Frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Baseline, 4 weeks into intervention and end of 8 week intervention
Hip circumference
Time Frame: Every 2 weeks over the 8 week intervention
Every 2 weeks over the 8 week intervention
Flow Mediated Dilation (FMD)
Time Frame: At the end of 8 week intervention
As a measure of endothelial function
At the end of 8 week intervention
Urinary 8-isoprostane
Time Frame: Baseline and end of 8 week intervention
Baseline and end of 8 week intervention
Urinary electrolytes
Time Frame: Baseline and end of 8 week intervention
Baseline and end of 8 week intervention
Urinary angiotensinogen
Time Frame: Baseline and end of 8 week intervention
Baseline and end of 8 week intervention
Urinary creatinine clearance
Time Frame: Baseline and end of 8 week intervention
Baseline and end of 8 week intervention
Fasting lipid profile
Time Frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Baseline, 4 weeks into intervention and end of 8 week intervention
Physical activity
Time Frame: Baseline, 4 weeks into intervention and end of 8 week intervention
Research Tracker 6 (RT6) accelerometers
Baseline, 4 weeks into intervention and end of 8 week intervention
Hepatic glucose metabolism
Time Frame: End of 8 week intervention
Isotopic dilution
End of 8 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Merced

Investigators

  • Principal Investigator: Rudy Ortiz, PhD, UNIV OF CALIFORNIA MERCED

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UCM2016-86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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