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

NCT03084003 | Completed

• 1 other identifier: UCM2016-86
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diet Intervention

Outcome Measures

Primary Outcomes (4)

• Change in fasting blood glucose

  Change from baseline at 8 weeks

• 2-hour oral glucose tolerance test

  At the end of 8 week intervention

• Change in fasting blood insulin

  Change from baseline at 8 weeks

• Change in stool microbiome profiles

  Change from baseline at 8 weeks

Secondary Outcomes (14)

• Weight

  Every 2 weeks over the 8 week intervention

• Body composition

  Every 2 weeks over the 8 week intervention

• Waist circumference

  Every 2 weeks over the 8 week intervention

• Blood pressure

  Every 2 weeks over the 8 week intervention

• 24-hour appetite ratings

  Baseline, 4 weeks into intervention and end of 8 week intervention

Study Arms (2)

Almond group

EXPERIMENTAL

2 oz. of almonds everyday for 8 weeks

Dietary Supplement: Almonds

Control group

ACTIVE COMPARATOR

Isoenergetic control group 5 graham cracker sheets everyday for 8 weeks

Dietary Supplement: Graham crackers

Interventions

Almonds DIETARY_SUPPLEMENT

Almond group

Graham crackers DIETARY_SUPPLEMENT

Control group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Merced: lead

Study Sites (1)

University of California, Merced

Merced, California, 95343, United States

Location

Related Publications (29)

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• 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.

  PMID: 39965269 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.

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• 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.

  PMID: 35512761 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.

  PMID: 31528836 DERIVED

Related Links

• Nuts for diabetes prevention and management
• Adolescent Health in the United States, 2007
• Reduced physical activity levels associated with obesity in rural Hispanic adolescent females.

Study Officials

• Rudy Ortiz, PhD

  UNIV OF CALIFORNIA MERCED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 20, 2017
• Study Start: February 18, 2016
• Primary Completion: May 1, 2017
• Study Completion: February 1, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)