The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.

NCT03940105 | Completed

• 1 other identifier: 1807020783
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized snack study in normal to obese adults that will test whether snack size, choice, or variety has an influence on daily snack intake. Aim 1: To validate the in-house packout methodology with 3-day dietary recalls. Aim 2: To examine whether snack variety or snack package size will influence free-living snacking behavior. Aim 3: To identify whether a correlation exists between mindful eating and free-living snacking behavior.

Conditions

Snacking

Keywords

intuitive eating; package size; food variety

Outcome Measures

Primary Outcomes (2)

• Ad libitum Snack Energy Intake

  Free-living energy intake will be assessed on the three testing days of each testing arm. For the control testing days, the participant will be provided with a standardized breakfast, lunch, and dinner, and will be required to log any snacks consumed on the Automated Self-Administered Recall System (ASA24). For each pack-out testing day, the participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snacking and daily energy intake (as well as protein, carbohydrate, sugar, fiber, and fat intake) will be assessed from these pack-outs.

  12 testing days across ~4-6 weeks

• Ad libitum Food Category Intake

  Free-living food category intake will be assessed on the three testing days of each packout. The participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snack intake of different food categories (i.e. desserts and candy, salty, high fat, high sugar, fruits and vegetables) will be assessed from these pack-outs.

  9 testing days across ~3-5 weeks

Secondary Outcomes (1)

• Intuitive Eating Score (1-5)

  Baseline (at beginning of study)

Study Arms (4)

Control

NO INTERVENTION

For 3 days during the control snack pattern, the participants will be asked to complete dietary recalls concerning their afternoon and evening snacking behavior. The participants will use the Automated Self-Administered 24-hour Recall (ASA24) system which was developed by the National Cancer Institute.

Standard Packout

ACTIVE COMPARATOR

This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch.

Behavioral: Packout

Large Package Packout

ACTIVE COMPARATOR

This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that the package sizes of all the foods are larger (though food amount remains the same).

Behavioral: Packout

Variety Packout

ACTIVE COMPARATOR

This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that there is about twice as much snack variety (though food amount remains the same).

Behavioral: Packout

Interventions

Packout BEHAVIORAL

Each packout provided during 3 of the 4 snack patterns will contain a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. There are 3 different packouts that will be provided for 3 nonconsecutive weekdays (for a total of 9 packouts). Each packout contains the same calories and types of foods. However, they differ in packaging size and variety.

Large Package Packout; Standard Packout; Variety Packout

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age range 18-55 y
• normal weight to overweight/obese (BMI: 18-32 kg/m2)
• healthy, non-diabetic
• not currently or previously on a weight loss or other special diet (in the past 6 months)
• non-smoking (for the past 6 months)
• not been clinically diagnosed with an eating disorder
• habitually eat afternoon/evening snacks at least 4 days/week

You may not qualify if:

• Clinically diagnosed with an eating disorder
• Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
• Currently or previously on a weight loss or other special diet (in the past 6 months)
• Gained/lost \>10 lb. over the past 6 months
• Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 3 months)
• Not willing or able to complete all study testing procedures

Sponsors & Collaborators

• Purdue University: lead
• Sabra Dipping Company, LLC: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

• Reister EJ, Leidy HJ. Snack Package Size and Variety Differentially Influence Energy Intake and Food Choices in Healthy Adults. Curr Dev Nutr. 2022 Jan 17;6(2):nzac004. doi: 10.1093/cdn/nzac004. eCollection 2022 Feb.

  PMID: 35155984 DERIVED

Study Officials

• Heather J Leidy, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: tightly-controlled, randomized cross-over design

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After 6 months following the publication of the study data, data requests can be submitted for approval. The data will be available for up to 24 months post-publication.
• Access Criteria: Access can be requested by qualified researchers engaging in independent scientific research. For more information or to submit a request, please contact Heather Leidy at Heather.Leidy@austin.utexas.edu.

Locations

US (1)