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Completed

NCT Number: NCT03236116

Almond Consumption and Glycemia

This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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About this study

There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.

Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
  • 18-60 years
  • no nut allergies

Exclusion criteria

  • Not meeting one of the body fat distribution criteria
  • allergic to nuts

Treatment and study plan

Almonds

Other

Participants will consume almonds everyday for 6 months.

Control (no nuts)

Other

Participants will not be permited to consume any nuts for 6 months.

Primary outcomes

  1. HbA1c

    Time frame: Baseline

    HbA1c.

  2. fasting glucose

    Time frame: Baseline

    fasting glucose,

  3. fasting triglycerides

    Time frame: Baseline

    fasting triglycerides

  4. Change in Body weight

    Time frame: Every two weeks for 6 months.

    Body weight

  5. Body composition

    Time frame: Baseline

    Body composition

  6. GLP-1

    Time frame: Baseline

    GLP-1

  7. Change in HbA1c

    Time frame: 6 months

    HbA1c.

  8. Change in fasting glucose

    Time frame: 6 months

    fasting glucose

  9. fasting triglycerides

    Time frame: 6 months

    fasting triglycerides

  10. Change in Body composition

    Time frame: 6 months

    Body composition

  11. Change in GLP-1

    Time frame: 6 months

    GLP-1

  12. fasting insulin

    Time frame: Baseline

    fasting insulin

  13. total cholesterol

    Time frame: Baseline

    total cholesterol

  14. LDL-cholesterol

    Time frame: Baseline

    LDL-cholesterol

  15. HDL-cholesterol

    Time frame: Baseline

    HDL-cholesterol

  16. GIP

    Time frame: Baseline

    GIP

  17. change in fasting insulin

    Time frame: 6 months

    fasting insulin

  18. change in total cholesterol

    Time frame: 6 months

    total cholesterol

  19. change in LDL-cholesterol

    Time frame: 6 months

    LDL-cholesterol

  20. change in HDL-cholesterol

    Time frame: 6 months

    HDL-cholesterol

  21. change in GIP

    Time frame: 6 months

    GIP

  22. C-peptide

    Time frame: baseline

  23. C-peptide

    Time frame: 6 months

  24. Homa-IR

    Time frame: baseline

  25. Homa-IR

    Time frame: 6 months

  26. Homa-Percent Beta

    Time frame: Baseline

  27. Homa-Percent Beta

    Time frame: 6 months

Secondary outcomes

  1. Diet Quality

    Time frame: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.

    Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.

  2. Compliance

    Time frame: Baseline, month 2, 4, and 6.

    Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Almond Board of California

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2017
Registry last updated
Jan 7, 2021

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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