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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pecan snack
Tortilla chip snack
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Pecans, appetite, hormones, food intake

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Anschutz Health and Wellness CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pecan snack condition

Tortilla chip snack condition

Arm Description

In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered.

In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered.

Outcomes

Primary Outcome Measures

Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
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".
Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
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".
Energy intake response to pecan or pretzel snack using weighed food intake measures
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.
Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
Serum glucose by enzymatic method.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
Serum glucose by enzymatic method.
Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
Serum insulin by radio-immunoassay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
Serum insulin by radio-immunoassay.
Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
Serum triglycerides by enzymatic assay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
Serum triglycerides by enzymatic assay.
Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
Serum free fatty acids by enzymatic assay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
Serum free fatty acids by enzymatic assay.
Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
Serum ghrelin by radio-immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
Serum ghrelin by radio-immunoassay
Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
Serum peptide YY (PYY) by radio-immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
Serum peptide YY (PYY) by radio-immunoassay
Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Change in serum leptin from baseline to 120 minutes following snack consumption
Serum leptin by immunoassay.

Secondary Outcome Measures

Change from baseline in energy expenditure post snack
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).
Change from baseline in energy expenditure post lunch
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).

Full Information

First Posted
June 26, 2020
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
Collaborators
American Pecan Council
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1. Study Identification

Unique Protocol Identification Number
NCT04484974
Brief Title
Effects of Pecan Nut Snacks v Equicaloric Snacks on Appetite, Food Intake, Metabolism, Hormones and Biomarkers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Pecan Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Pecans, appetite, hormones, food intake

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, two period crossover with two treatment conditions
Masking
None (Open Label)
Masking Description
The two treatments are pecan nuts or tortilla chips as snacks, therefore masking of treatment conditions is not possible.
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pecan snack condition
Arm Type
Experimental
Arm Description
In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered.
Arm Title
Tortilla chip snack condition
Arm Type
Active Comparator
Arm Description
In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered.
Intervention Type
Other
Intervention Name(s)
Pecan snack
Intervention Description
Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.
Intervention Type
Other
Intervention Name(s)
Tortilla chip snack
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
Description
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".
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.
Title
Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
Description
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".
Time Frame
Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
Title
Energy intake response to pecan or pretzel snack using weighed food intake measures
Description
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.
Time Frame
30 minutes allowed for completion of the lunch meal
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
Description
Serum glucose by enzymatic method.
Time Frame
Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
Description
Serum glucose by enzymatic method.
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
Description
Serum insulin by radio-immunoassay.
Time Frame
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
Description
Serum insulin by radio-immunoassay.
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
Description
Serum triglycerides by enzymatic assay.
Time Frame
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
Description
Serum triglycerides by enzymatic assay.
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
Description
Serum free fatty acids by enzymatic assay.
Time Frame
Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
Description
Serum free fatty acids by enzymatic assay.
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
Description
Serum ghrelin by radio-immunoassay
Time Frame
Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
Description
Serum ghrelin by radio-immunoassay
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
Description
Serum peptide YY (PYY) by radio-immunoassay
Time Frame
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
Description
Serum peptide YY (PYY) by radio-immunoassay
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
Description
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Time Frame
Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Title
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
Description
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Time Frame
Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Title
Change in serum leptin from baseline to 120 minutes following snack consumption
Description
Serum leptin by immunoassay.
Time Frame
Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
Secondary Outcome Measure Information:
Title
Change from baseline in energy expenditure post snack
Description
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).
Time Frame
Resting energy expenditure will be measured for 20 minutes after snack consumption.
Title
Change from baseline in energy expenditure post lunch
Description
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).
Time Frame
Resting energy expenditure will be measured for 20 minutes after lunch consumption.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 35 adult men and women all ethnic groups ages 20-50, BMI 27-35, habitually eat breakfast, willing to eat the test snacks and other foods offered, weight stable for the last 6 months willing to consent and adhere to the test procedures and schedule Exclusion Criteria: nut allergies, uncontrolled thyroid disorders, diabetes mellitus, eating disorders, pregnant, or planning to become pregnant during the study, lactating, uncontrolled hypertension, active dieting intensive physical activity training regimen (>300 min/wk exercise), medical history or current medication that may affect study outcomes per study PI discretion consuming pecans on a regular basis unable to lie still with a clear hood over their head for the measurement of energy expenditure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John C Peters, PhD
Phone
13037249160
Email
john.c.peters@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Anne Breen, MS
Phone
13037249015
Email
jeanneanne.breen@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Peters, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Health and Wellness Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John C Peters, PhD
Phone
303-724-9160
Email
john.c.peters@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jeanne Anne Breen, MS
Phone
303-724-9015
Email
jeanneanne.breen@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Marc A Cornier, MD
First Name & Middle Initial & Last Name & Degree
John C Peters, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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