Effects of Pecan Nut Snacks v Equicaloric Snacks on Appetite, Food Intake, Metabolism, Hormones and Biomarkers

July 2, 2024 updated by: University of Colorado, Denver

A Randomized, Two Condition, Crossover Trial Assessing Appetite, Energy Metabolism, Blood Biomarker and ad Libitum Food Intake Responses to a Mid-morning Pecan Snack vs. an Equicaloric High Carbohydrate Savory Snack in Healthy Volunteers With Overweight/Obesity

This is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially devoid of fat. These two very different nutrient profiles should elicit different metabolic and biomarker responses. The study aims to determine whether these treatments also elicit different subjective appetite and food intake responses. Participants will be healthy volunteers with overweight and obesity, a population that may be seeking healthy snacking options that are satisfying and satiating.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, two condition, crossover study in healthy individuals with overweight and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum food intake at lunch. Twenty-four participants will be enrolled and studied on two test days with at least one week washout in between. On test days, participants will have baseline measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry) taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the snack and RMR will be measured for 20 min after eating. Participants will be given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness and reduced hunger after the snack and lunch meal consumption (on either a calorie per calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and lunch energy expenditure and fat oxidation will also be compared between treatments as an exploratory aim.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Health and Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 35 adult men and women
  2. all ethnic groups
  3. ages 20-50,
  4. BMI 27-35,
  5. habitually eat breakfast,
  6. willing to eat the test snacks and other foods offered,
  7. weight stable for the last 6 months
  8. willing to consent and adhere to the test procedures and schedule

Exclusion Criteria:

  1. nut allergies,
  2. uncontrolled thyroid disorders,
  3. diabetes mellitus,
  4. eating disorders,
  5. pregnant, or planning to become pregnant during the study,
  6. lactating,
  7. uncontrolled hypertension,
  8. active dieting
  9. intensive physical activity training regimen (>300 min/wk exercise),
  10. medical history or current medication that may affect study outcomes per study PI discretion
  11. consuming pecans on a regular basis
  12. unable to lie still with a clear hood over their head for the measurement of energy expenditure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pecan snack condition
In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered.
Other: Pecan snack
Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.
Active Comparator: Tortilla chip snack condition
In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered.
Other: Tortilla chip snack
Under this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of tortilla chips followed by an ad libitum lunch.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
Time Frame: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
Time Frame: Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
Energy intake response to pecan or pretzel snack using weighed food intake measures
Time Frame: 30 minutes allowed for completion of the lunch meal
Energy intake at ad libitum lunch meal consisting of a variety of different foods offering approximately 1400 of kilocalories of energy having an overall composition of approximately 15% protein, 55% carbohydrate and 30% fat. Twelve ounces of water will be provided as the beverage. Energy intake will be calculated from the weight of each food consumed and the published nutrient composition of the foods. Linear mixed effects model will be used to test the difference in energy intake between two experimental conditions.
30 minutes allowed for completion of the lunch meal
Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
Time Frame: Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
Serum glucose by enzymatic method.
Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum glucose by enzymatic method.
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
Time Frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum insulin by radio-immunoassay.
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum insulin by radio-immunoassay.
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
Time Frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum triglycerides by enzymatic assay.
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum triglycerides by enzymatic assay.
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
Time Frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum free fatty acids by enzymatic assay.
Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum free fatty acids by enzymatic assay.
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
Time Frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum ghrelin by radio-immunoassay
Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum ghrelin by radio-immunoassay
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
Time Frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum peptide YY (PYY) by radio-immunoassay
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum peptide YY (PYY) by radio-immunoassay
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
Time Frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
Time Frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change in serum leptin from baseline to 120 minutes following snack consumption
Time Frame: Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
Serum leptin by immunoassay.
Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in energy expenditure post snack
Time Frame: Resting energy expenditure will be measured for 20 minutes after snack consumption.
Post snack resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
Resting energy expenditure will be measured for 20 minutes after snack consumption.
Change from baseline in energy expenditure post lunch
Time Frame: Resting energy expenditure will be measured for 20 minutes after lunch consumption.
Post lunch resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
Resting energy expenditure will be measured for 20 minutes after lunch consumption.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Pecan Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John C Peters, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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