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Are All Snacks Created Equal?

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ClinicalTrials.gov Identifier: NCT03940105
Recruitment Status : Completed
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Sabra Dipping Company, LLC
Information provided by (Responsible Party):
Heather Leidy, Purdue University

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.


Condition or disease Intervention/treatment Phase
Snacking Behavioral: Packout Not Applicable

Detailed Description:

Participants will complete 4 different snack patterns. Each pattern will include 3 nonconsecutive weekdays (i.e., Monday/Wednesday/Friday; Tuesday/Thursday/Monday, etc.). The snack patterns will be performed at home/work.

The first pattern will simply be a measurement of typical snack habits. For each of the 3 days, the participant will enter all foods and beverages consumed using the online program, Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).

For the other 3 patterns, different snack packouts will be provided to the participant for 3 nonconsecutive weekdays/pattern. The only difference between the packouts is the type of foods provided. The packouts contain commercially available foods commonly eaten by people who snack. Following lunch, the participant will be permitted to eat as much or as little as he/she chooses from the packout until going to bed. Beverages will not be provided and the participant could drink whatever he/she typically consumes.

For all patterns, the participant will be provided with a standardized breakfast, lunch, and dinner to consume at home/work for each of the 3 days/pattern.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: tightly-controlled, randomized cross-over design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Are All Snacks Created Equal?
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Arm Intervention/treatment
No Intervention: Control
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.
Active Comparator: Standard Packout
This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch.
Behavioral: Packout
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.

Active Comparator: Large Package Packout
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
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.

Active Comparator: Variety Packout
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
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.




Primary Outcome Measures :
  1. Ad libitum Snack Energy Intake [ Time Frame: 12 testing days across ~4-6 weeks ]
    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.

  2. Ad libitum Food Category Intake [ Time Frame: 9 testing days across ~3-5 weeks ]
    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.

  3. Intuitive Eating Score [ Time Frame: Baseline (at beginning of study) ]
    Participant will complete Intuitive Eating Scale-2 survey in order to receive an Intuitive Eating Score.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Clinically diagnosed with an eating disorder
  2. Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
  3. Currently or previously on a weight loss or other special diet (in the past 6 months)
  4. Gained/lost >10 lb. over the past 6 months
  5. 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)
  6. Not willing or able to complete all study testing procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940105


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Sabra Dipping Company, LLC
Investigators
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Principal Investigator: Heather J Leidy, PhD Purdue University

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Responsible Party: Heather Leidy, Associate Professor, Purdue University
ClinicalTrials.gov Identifier: NCT03940105     History of Changes
Other Study ID Numbers: 1807020783
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heather Leidy, Purdue University:
intuitive eating
package size
food variety