Clinical trial NCT03084003: Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials
Official title: Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials: Implications of Systemic Glucoregulatory Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Intervention
Lead sponsor: University of California, Merced
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in fasting blood glucose
timeFrame: Change from baseline at 8 weeks
measure: 2-hour oral glucose tolerance test
timeFrame: At the end of 8 week intervention
measure: Change in fasting blood insulin
timeFrame: Change from baseline at 8 weeks
measure: Change in stool microbiome profiles
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Weight
timeFrame: Every 2 weeks over the 8 week intervention
measure: Body composition
timeFrame: Every 2 weeks over the 8 week intervention
measure: Waist circumference
timeFrame: Every 2 weeks over the 8 week intervention
measure: Blood pressure
timeFrame: Every 2 weeks over the 8 week intervention
measure: 24-hour appetite ratings
timeFrame: Baseline, 4 weeks into intervention and end of 8 week intervention
measure: Hip circumference
timeFrame: Every 2 weeks over the 8 week intervention
measure: Flow Mediated Dilation (FMD)
timeFrame: At the end of 8 week intervention
measure: Urinary 8-isoprostane
timeFrame: Baseline and end of 8 week intervention
measure: Urinary electrolytes
timeFrame: Baseline and end of 8 week intervention
measure: Urinary angiotensinogen
timeFrame: Baseline and end of 8 week intervention
measure: Urinary creatinine clearance
timeFrame: Baseline and end of 8 week intervention
measure: Fasting lipid profile
timeFrame: Baseline, 4 weeks into intervention and end of 8 week intervention
measure: Physical activity
timeFrame: Baseline, 4 weeks into intervention and end of 8 week intervention
measure: Hepatic glucose metabolism
timeFrame: End of 8 week intervention
Other outcomes:
Locations:
city: Merced
country: United States
facility: University of California, Merced
state: California
Study officials:
affiliation: UNIV OF CALIFORNIA MERCED
name: Rudy Ortiz, PhD
role: PRINCIPAL_INVESTIGATOR
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