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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03084003
Enrollment
74
Registered
2017-03-20
Start date
2016-02-18
Completion date
2019-02-01
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Intervention

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTAlmonds
DIETARY_SUPPLEMENTGraham crackers

Sponsors

University of California, Merced
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 22 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Change in fasting blood glucoseChange from baseline at 8 weeks
2-hour oral glucose tolerance testAt the end of 8 week intervention
Change in fasting blood insulinChange from baseline at 8 weeks
Change in stool microbiome profilesChange from baseline at 8 weeks

Secondary

MeasureTime frameDescription
Physical activityBaseline, 4 weeks into intervention and end of 8 week interventionResearch Tracker 6 (RT6) accelerometers
Hepatic glucose metabolismEnd of 8 week interventionIsotopic dilution
WeightEvery 2 weeks over the 8 week intervention
Body compositionEvery 2 weeks over the 8 week intervention
Waist circumferenceEvery 2 weeks over the 8 week intervention
Urinary electrolytesBaseline and end of 8 week intervention
24-hour appetite ratingsBaseline, 4 weeks into intervention and end of 8 week intervention
Hip circumferenceEvery 2 weeks over the 8 week intervention
Flow Mediated Dilation (FMD)At the end of 8 week interventionAs a measure of endothelial function
Urinary 8-isoprostaneBaseline and end of 8 week intervention
Blood pressureEvery 2 weeks over the 8 week intervention
Urinary angiotensinogenBaseline and end of 8 week intervention
Urinary creatinine clearanceBaseline and end of 8 week intervention
Fasting lipid profileBaseline, 4 weeks into intervention and end of 8 week intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026