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Completed

NCT Number: NCT03084003

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

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

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Key information

Conditions

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Merced

Merced, California, 95343, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Almonds

Dietary Supplement

Graham crackers

Dietary Supplement

Primary outcomes

  1. Change in fasting blood glucose

    Time frame: Change from baseline at 8 weeks

  2. 2-hour oral glucose tolerance test

    Time frame: At the end of 8 week intervention

  3. Change in fasting blood insulin

    Time frame: Change from baseline at 8 weeks

  4. Change in stool microbiome profiles

    Time frame: Change from baseline at 8 weeks

Secondary outcomes

  1. Weight

    Time frame: Every 2 weeks over the 8 week intervention

  2. Body composition

    Time frame: Every 2 weeks over the 8 week intervention

  3. Waist circumference

    Time frame: Every 2 weeks over the 8 week intervention

  4. Blood pressure

    Time frame: Every 2 weeks over the 8 week intervention

  5. 24-hour appetite ratings

    Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention

  6. Hip circumference

    Time frame: Every 2 weeks over the 8 week intervention

  7. Flow Mediated Dilation (FMD)

    Time frame: At the end of 8 week intervention

    As a measure of endothelial function

  8. Urinary 8-isoprostane

    Time frame: Baseline and end of 8 week intervention

  9. Urinary electrolytes

    Time frame: Baseline and end of 8 week intervention

  10. Urinary angiotensinogen

    Time frame: Baseline and end of 8 week intervention

  11. Urinary creatinine clearance

    Time frame: Baseline and end of 8 week intervention

  12. Fasting lipid profile

    Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention

  13. Physical activity

    Time frame: Baseline, 4 weeks into intervention and end of 8 week intervention

    Research Tracker 6 (RT6) accelerometers

  14. Hepatic glucose metabolism

    Time frame: End of 8 week intervention

    Isotopic dilution

Sponsors and collaborators

Lead sponsor

University of California, Merced

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 20, 2017
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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