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

NCT04484974 | Completed

• 1 other identifier: 20-0048
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Pecans; appetite; hormones; food intake

Outcome Measures

Primary Outcomes (18)

• 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".

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Serum leptin by immunoassay.

  Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.

Secondary Outcomes (2)

• Change from baseline in energy expenditure post snack

  Resting energy expenditure will be measured for 20 minutes after snack consumption.

• Change from baseline in energy expenditure post lunch

  Resting energy expenditure will be measured for 20 minutes after lunch consumption.

Study Arms (2)

Pecan snack condition

EXPERIMENTAL

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

Other: Pecan snack

Tortilla chip snack condition

ACTIVE COMPARATOR

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

Other: Tortilla chip snack

Interventions

Pecan snack OTHER

Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.

Pecan snack condition

Tortilla chip snack OTHER

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.

Tortilla chip snack condition

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Pecan Council: collaborator

Study Sites (1)

University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John C Peters, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The two treatments are pecan nuts or tortilla chips as snacks, therefore masking of treatment conditions is not possible.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, two period crossover with two treatment conditions

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 24, 2020
• Study Start: June 23, 2020
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)