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Clinical Trials/NCT03940105
NCT03940105CompletedNot Applicable

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

Purdue University2 sites in 1 country31 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
2
Primary Endpoint
Ad libitum Snack Energy Intake

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Intuitive Eating Score (1-5)(Baseline (at beginning of study))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heather Leidy

Associate Professor

Purdue University

Study Sites (2)

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