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

Diet Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084003
• Other study ID #: UCM2016-86
• Status: Completed
• Phase: N/A
• Start date: February 18, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: May 2021
• Source: University of California, Merced
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 1, 2019
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Diet Intervention

Intervention

Dietary Supplement:
• Almonds

• Graham crackers

Locations

Country	Name	City	State
United States	University of California, Merced	Merced	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Merced

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Quehenberger O, Armando AM, Brown AH, Milne SB, Myers DS, Merrill AH, Bandyopadhyay S, Jones KN, Kelly S, Shaner RL, Sullards CM, Wang E, Murphy RC, Barkley RM, Leiker TJ, Raetz CR, Guan Z, Laird GM, Six DA, Russell DW, McDonald JG, Subramaniam S, Fahy E, Dennis EA. Lipidomics reveals a remarkable diversity of lipids in human plasma. J Lipid Res. 2010 Nov;51(11):3299-305. doi: 10.1194/jlr.M009449. Epub 2010 Jul 29. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting blood glucose		Change from baseline at 8 weeks
Primary	2-hour oral glucose tolerance test		At the end of 8 week intervention
Primary	Change in fasting blood insulin		Change from baseline at 8 weeks
Primary	Change in stool microbiome profiles		Change from baseline at 8 weeks
Secondary	Weight		Every 2 weeks over the 8 week intervention
Secondary	Body composition		Every 2 weeks over the 8 week intervention
Secondary	Waist circumference		Every 2 weeks over the 8 week intervention
Secondary	Blood pressure		Every 2 weeks over the 8 week intervention
Secondary	24-hour appetite ratings		Baseline, 4 weeks into intervention and end of 8 week intervention
Secondary	Hip circumference		Every 2 weeks over the 8 week intervention
Secondary	Flow Mediated Dilation (FMD)	As a measure of endothelial function	At the end of 8 week intervention
Secondary	Urinary 8-isoprostane		Baseline and end of 8 week intervention
Secondary	Urinary electrolytes		Baseline and end of 8 week intervention
Secondary	Urinary angiotensinogen		Baseline and end of 8 week intervention
Secondary	Urinary creatinine clearance		Baseline and end of 8 week intervention
Secondary	Fasting lipid profile		Baseline, 4 weeks into intervention and end of 8 week intervention
Secondary	Physical activity	Research Tracker 6 (RT6) accelerometers	Baseline, 4 weeks into intervention and end of 8 week intervention
Secondary	Hepatic glucose metabolism	Isotopic dilution	End of 8 week intervention

External Links

•   Adolescent Health in the United States, 2007
•   Childhood Obes. The Lancet.
•   Nuts for diabetes prevention and management
•   Reduced physical activity levels associated with obesity in rural Hispanic adolescent females.
•   What do college students eat? Food selection and meal pattern