Effects of Almond Consumption on Cardiovascular, Metabolomic, and Microbiome Profiles in Millennials
NCT ID: NCT03084003
Last Updated: 2021-05-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-02-18
Study Completion Date
2019-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of the study is to examine the effects of almond snacking on metabolic, cardiovascular and microbiome profiles in college freshmen.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Almonds to Improve Gut Health and Decrease Inflammation
NCT05790564
Metabolic Syndrome
Dysbiosis
Inflammation
ACTIVE_NOT_RECRUITING
NA
Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health
NCT04223323
Overweight and Obesity
COMPLETED
NA
Metabolic Effects of Almond in the Longer-term Study
NCT01690936
Obesity
COMPLETED
NA
Almonds: Digestive Health and Immune Function of Adults and Children
NCT01973595
Healthy
COMPLETED
NA
Effects of Almonds on Immune Health and Responsiveness
NCT05530499
Diet Intervention
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Diet Intervention
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Almond group
2 oz. of almonds everyday for 8 weeks
Group Type
EXPERIMENTAL
Almonds
Intervention Type
DIETARY_SUPPLEMENT
Control group
Isoenergetic control group 5 graham cracker sheets everyday for 8 weeks
Group Type
ACTIVE_COMPARATOR
Graham crackers
Intervention Type
DIETARY_SUPPLEMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Almonds
Intervention Type
DIETARY_SUPPLEMENT
Graham crackers
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
22 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Merced
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rudy Ortiz
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rudy Ortiz, PhD
Role: PRINCIPAL_INVESTIGATOR
UNIV OF CALIFORNIA MERCED
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Merced
Merced, California, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64.
Reference Type
BACKGROUND
Adams SH, Hoppel CL, Lok KH, Zhao L, Wong SW, Minkler PE, Hwang DH, Newman JW, Garvey WT. Plasma acylcarnitine profiles suggest incomplete long-chain fatty acid beta-oxidation and altered tricarboxylic acid cycle activity in type 2 diabetic African-American women. J Nutr. 2009 Jun;139(6):1073-81. doi: 10.3945/jn.108.103754. Epub 2009 Apr 15.
Reference Type
BACKGROUND
Berkey CS, Rockett HR, Gillman MW, Field AE, Colditz GA. Longitudinal study of skipping breakfast and weight change in adolescents. Int J Obes Relat Metab Disord. 2003 Oct;27(10):1258-66. doi: 10.1038/sj.ijo.0802402.
Reference Type
BACKGROUND
Brevard PB, Ricketts CD. Residence of college students affects dietary intake, physical activity, and serum lipid levels. J Am Diet Assoc. 1996 Jan;96(1):35-8. doi: 10.1016/S0002-8223(96)00011-9.
Reference Type
BACKGROUND
Cani PD, Delzenne NM. Gut microflora as a target for energy and metabolic homeostasis. Curr Opin Clin Nutr Metab Care. 2007 Nov;10(6):729-34. doi: 10.1097/MCO.0b013e3282efdebb.
Reference Type
BACKGROUND
Cohen AE, Johnston CS. Almond ingestion at mealtime reduces postprandial glycemia and chronic ingestion reduces hemoglobin A(1c) in individuals with well-controlled type 2 diabetes mellitus. Metabolism. 2011 Sep;60(9):1312-7. doi: 10.1016/j.metabol.2011.01.017. Epub 2011 Apr 12.
Reference Type
BACKGROUND
Devitt AA, Kuevi A, Coelho SB, Lartey A, Lokko P, Costa N, Bressan J, Mattes RD. Appetitive and Dietary Effects of Consuming an Energy-Dense Food (Peanuts) with or between Meals by Snackers and Nonsnackers. J Nutr Metab. 2011;2011:928352. doi: 10.1155/2011/928352. Epub 2011 Jan 22.
Reference Type
BACKGROUND
Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26.
Reference Type
BACKGROUND
Driskell JA, Kim YN, Goebel KJ. Few differences found in the typical eating and physical activity habits of lower-level and upper-level university students. J Am Diet Assoc. 2005 May;105(5):798-801. doi: 10.1016/j.jada.2005.02.004.
Reference Type
BACKGROUND
Fiehn O, Garvey WT, Newman JW, Lok KH, Hoppel CL, Adams SH. Plasma metabolomic profiles reflective of glucose homeostasis in non-diabetic and type 2 diabetic obese African-American women. PLoS One. 2010 Dec 10;5(12):e15234. doi: 10.1371/journal.pone.0015234.
Reference Type
BACKGROUND
Grapov D, Adams SH, Pedersen TL, Garvey WT, Newman JW. Type 2 diabetes associated changes in the plasma non-esterified fatty acids, oxylipins and endocannabinoids. PLoS One. 2012;7(11):e48852. doi: 10.1371/journal.pone.0048852. Epub 2012 Nov 8.
Reference Type
BACKGROUND
Heatherton TF, Nichols P, Mahamedi F, Keel P. Body weight, dieting, and eating disorder symptoms among college students, 1982 to 1992. Am J Psychiatry. 1995 Nov;152(11):1623-9. doi: 10.1176/ajp.152.11.1623.
Reference Type
BACKGROUND
Hoffman DJ, Policastro P, Quick V, Lee SK. Changes in body weight and fat mass of men and women in the first year of college: A study of the "freshman 15". J Am Coll Health. 2006 Jul-Aug;55(1):41-5. doi: 10.3200/JACH.55.1.41-46.
Reference Type
BACKGROUND
Josse AR, Kendall CW, Augustin LS, Ellis PR, Jenkins DJ. Almonds and postprandial glycemia--a dose-response study. Metabolism. 2007 Mar;56(3):400-4. doi: 10.1016/j.metabol.2006.10.024.
Reference Type
BACKGROUND
Li SC, Liu YH, Liu JF, Chang WH, Chen CM, Chen CY. Almond consumption improved glycemic control and lipid profiles in patients with type 2 diabetes mellitus. Metabolism. 2011 Apr;60(4):474-9. doi: 10.1016/j.metabol.2010.04.009. Epub 2010 May 23.
Reference Type
BACKGROUND
Luo C, Zhang Y, Ding Y, Shan Z, Chen S, Yu M, Hu FB, Liu L. Nut consumption and risk of type 2 diabetes, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis. Am J Clin Nutr. 2014 Jul;100(1):256-69. doi: 10.3945/ajcn.113.076109. Epub 2014 May 21.
Reference Type
BACKGROUND
Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The spread of the obesity epidemic in the United States, 1991-1998. JAMA. 1999 Oct 27;282(16):1519-22. doi: 10.1001/jama.282.16.1519.
Reference Type
BACKGROUND
Mori AM, Considine RV, Mattes RD. Acute and second-meal effects of almond form in impaired glucose tolerant adults: a randomized crossover trial. Nutr Metab (Lond). 2011 Jan 28;8(1):6. doi: 10.1186/1743-7075-8-6.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Rodriguez R, Mowrer J, Romo J, Aleman A, Weffer SE, Ortiz RM. Ethnic and gender disparities in adolescent obesity and elevated systolic blood pressure in a rural US population. Clin Pediatr (Phila). 2010 Sep;49(9):876-84. doi: 10.1177/0009922810368135. Epub 2010 Jun 3.
Reference Type
BACKGROUND
Smith KJ, Gall SL, McNaughton SA, Blizzard L, Dwyer T, Venn AJ. Skipping breakfast: longitudinal associations with cardiometabolic risk factors in the Childhood Determinants of Adult Health Study. Am J Clin Nutr. 2010 Dec;92(6):1316-25. doi: 10.3945/ajcn.2010.30101. Epub 2010 Oct 6.
Reference Type
BACKGROUND
Tan SY, Mattes RD. Appetitive, dietary and health effects of almonds consumed with meals or as snacks: a randomized, controlled trial. Eur J Clin Nutr. 2013 Nov;67(11):1205-14. doi: 10.1038/ejcn.2013.184. Epub 2013 Oct 2.
Reference Type
BACKGROUND
Vella-Zarb RA, Elgar FJ. The 'freshman 5': a meta-analysis of weight gain in the freshman year of college. J Am Coll Health. 2009 Sep-Oct;58(2):161-6. doi: 10.1080/07448480903221392.
Reference Type
BACKGROUND
Wien MA, Sabate JM, Ikle DN, Cole SE, Kandeel FR. Almonds vs complex carbohydrates in a weight reduction program. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1365-72. doi: 10.1038/sj.ijo.0802411.
Reference Type
BACKGROUND
Zivkovic AM, German JB. Metabolomics for assessment of nutritional status. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):501-7. doi: 10.1097/MCO.0b013e32832f1916.
Reference Type
BACKGROUND
Dhillon J, Pandey S, Newman JW, Fiehn O, Ortiz RM. Almond consumption for 8 weeks differentially modulates metabolomic responses to an acute glucose challenge compared to crackers in young adults. Nutr Res. 2025 Mar;135:67-81. doi: 10.1016/j.nutres.2025.01.003. Epub 2025 Jan 8.
Reference Type
DERIVED
Dhillon J, Pandey S, Newman JW, Fiehn O, Ortiz RM. Metabolic Responses to an Acute Glucose Challenge: The Differential Effects of Eight Weeks of Almond vs. Cracker Consumption in Young Adults. medRxiv [Preprint]. 2024 May 20:2024.05.19.24307571. doi: 10.1101/2024.05.19.24307571.
Reference Type
DERIVED
Dhillon J, Newman JW, Fiehn O, Ortiz RM. Almond Consumption for 8 Weeks Altered Host and Microbial Metabolism in Comparison to a Control Snack in Young Adults. J Am Nutr Assoc. 2023 Mar-Apr;42(3):242-254. doi: 10.1080/07315724.2021.2025168. Epub 2022 Feb 23.
Reference Type
DERIVED
Dhillon J, Li Z, Ortiz RM. Almond Snacking for 8 wk Increases Alpha-Diversity of the Gastrointestinal Microbiome and Decreases Bacteroides fragilis Abundance Compared with an Isocaloric Snack in College Freshmen. Curr Dev Nutr. 2019 Jul 3;3(8):nzz079. doi: 10.1093/cdn/nzz079. eCollection 2019 Aug.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60171-7/abstract
Childhood Obes. The Lancet.
http://www.fda.gov.tw/upload/189/Content/2014012817285169148.pdf
Nuts for diabetes prevention and management
https://www.cdc.gov/nchs/data/misc/adolescent2007.pdf
Adolescent Health in the United States, 2007
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCM2016-86
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Almond for Physical Performance
NCT04787718
COMPLETED
NA
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
NCT00782015
COMPLETED
NA
Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action
NCT01007188
COMPLETED
NA
Almonds and Health Effects on Metabolism, Vascular Function and Cognition
NCT03419702
COMPLETED
NA
Exploring the Role of Almonds in Enhancing Immune Strength
NCT05059639
COMPLETED
NA
The Effects of Including Almonds in a Weight Loss Trial
NCT02360787
COMPLETED
NA
The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
NCT02034383
COMPLETED
NA
The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin
NCT04352504
COMPLETED
NA
Effect of Macadamia Nut on Cardiometabolic Risk Factors
NCT03801837
COMPLETED
NA
Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease
NCT01038362
COMPLETED
NA
Availability of Lipids in Almonds in Healthy Individuals
NCT00768417
COMPLETED
Healthy Unique Lipids From Almonds
NCT05782218
COMPLETED
NA
The Effect of a Healthy Snack on Body Weight and Composition
NCT03159689
COMPLETED
NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
NCT03375866
RECRUITING
NA
Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
NCT03801486
COMPLETED
Effects of a Single Dose of Brazil Nuts on Blood Lipids
NCT05537324
COMPLETED
NA
Effect of Pistachios on Muscle Recovery
NCT03698032
COMPLETED
NA
The Metabolic Effect of Walnuts in Healthy Subjects
NCT02329067
COMPLETED
NA
Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Nutritive Microcirculatory Patterns
NCT00937599
COMPLETED
NA
Examination of the Effects of Four Different Spices on Energy Metabolism
NCT00611156
COMPLETED
NA
Pistachio Intake, Satiety and Body Weight Control in Healthy Adult Women
NCT03526120
UNKNOWN
NA
Pistachios, Performance, Metabolomics
NCT01821820
COMPLETED
NA
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
NCT01990391
COMPLETED
NA
Pistachio Snacking and Metabolic Flexibility
NCT07340125
RECRUITING
NA
Grape Seed Extract and Postprandial Oxidation and Inflammation
NCT01190358
COMPLETED
NA