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Completed

NCT Number: NCT04223323

Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health

The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males & Females
  • 30-60 years of age
  • BMI 25-34.9 kg/m^2
  • Ability to drop off fecal sample within 15 minutes of defecation

Exclusion criteria

  • Physician diagnosed metabolic or gastrointestinal diseases
  • Fasting blood glucose >126 mg/dL
  • Blood pressure >160/100 mm Hg
  • Anemia
  • Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
  • Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
  • Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function.
  • Pregnant, breastfeeding or postmenopausal
  • Smoker, tobacco use
  • Allergic to nuts
  • Consume > 2 alcoholic beverages/day
  • Abuse drugs
  • Have had > 5% weight change in the past month or > 10% change in the past year
  • Have taken antibiotics during the previous 2 months
  • Unable to consume the experimental treatments (almonds or pretzels)
  • Bariatric surgery
  • Gallbladder removal
  • Allergic to lidocaine or other topical anesthetics

Treatment and study plan

Almonds

Dietary Supplement

Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.

Pretzels

Dietary Supplement

Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.

Primary outcomes

  1. Changes in gastrointestinal microbiota composition

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.

  2. Changes in abundance of fecal Roseburia spp

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.

  3. Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.

  4. Changes in gastrointestinal microbial-derived metabolite concentrations

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.

Secondary outcomes

  1. Changes in liver fat

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.

  2. Changes in glycemic control.

    Time frame: Baseline & 12-week mark

    Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.

  3. Changes in secondary measures of gastrointestinal health.

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on gastrointestinal health compared to control (pretzels) by measuring fecal pH; other microbial fermentation end products and microbial-derived bile acids using gas-liquid chromatography; and alpha- and beta- diversity measures of the gut microbiota community structure using 16S microbiota analyses.

Other outcomes

  1. Changes in markers of systemic inflammation & metabolism

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on inflammation and metabolism compared to control (pretzels) by measuring biomarker concentrations with ELISA. Specifically, we will look at TNF, CRP, & LPS-BP (inflammatory) and NEFAs (metabolism).

  2. Changes in adiposity.

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on adiposity compared to control (pretzels) using a DXA scan.

  3. Changes in subjective measures of gastrointestinal health.

    Time frame: Baseline & 12-week mark

    Determine the impact of daily consumption of almonds on subjective measures of gut health compared to control (pretzels) using stool records. The questionnaire addresses questions related to gastrointestinal health including bloating, flatulence, and stool consistency.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism

Acronym: SNACKing

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2020
Registry last updated
Dec 6, 2024

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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