Effect on Dietary Compensation and Weight Gain in Adults by Savory Solid and Sugary Liquid Discretionary Food Sources
Primary Purpose
Weight Gain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discretionary calorie source
Sponsored by
About this trial
This is an interventional prevention trial for Weight Gain
Eligibility Criteria
Inclusion Criteria:
- Healthy adults
- overweight (BMI ≥ 25 kg/m2)
- consume sugar-sweetened beverages or savory snacks
- willing to consume amount of beverages and food provided to supplement usual dietary habits during the study period
Exclusion Criteria:
- Recently lost a significant amount of weight or looking to lose weight
- recently begun a new diet or exercise regimen
- prevalent or history of major illnesses or chronic disease (e.g. diabetes, heart disease, cancer, other metabolic disorders) which may affect adherence
- pregnant
- use of prescription medications (aside from birth control)
- report ≥ 1 alcoholic beverage a day
- currently smoke
- report being a restrained eater or having < 51% of control over the selection and preparation of the food they eat
- adults lacking capacity to consent for self
Sites / Locations
- West Bank Office Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Savory snack
Sugary beverage
Arm Description
1-2 assigned snacks to be taken in determined portions equivalent to 15% of dietary energy intake, chosen from 9-point hedonic preferences questionnaire completed by participant (chips, pretzels, etc.)
1-2 soda-based drinks/juice to be taken in determined portions equivalent to 15% of dietary energy intake, chosen from 9-point hedonic preferences questionnaire completed by participant (coke, sprite, etc.)
Outcomes
Primary Outcome Measures
Dietary energy compensation as measured by weight changes
Secondary Outcome Measures
Full Information
NCT ID
NCT02564874
First Posted
September 29, 2015
Last Updated
April 21, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02564874
Brief Title
Effect on Dietary Compensation and Weight Gain in Adults by Savory Solid and Sugary Liquid Discretionary Food Sources
Official Title
Effect on Dietary Compensation and Weight Gain in Adults by Savory Solid and Sugary Liquid Discretionary Food Sources
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to determine the effect different sources and forms of discretionary foods have on dietary compensation and energy intake in healthy adults in a free living, real world setting. Specifically, this pilot study will compare the effect of the greatest caloric sources of savory and sweetened discretionary foods in the American diet (savory snacks v. sugar-sweetened beverages). The rationale for conducting this study is to test the mechanism whereby sugar-sweetened beverages are hypothesized to relate to weight gain and obesity above and beyond other discretionary foods (lack of energy intake compensation due to liquid form of the beverage), since the evidence for this topic is limited. The subject population will be 20 men and women between the age of 18 and 59 who are overweight by body mass index (BMI ≥ 25 kg/m2), generally healthy, consume sugar-sweetened beverages or , and are willing to incorporate a sweetened beverage or a savory snack into their usual diet in the 4 week period.
Detailed Description
The study design will be a randomized parallel study consisting of a 4-week period during which each participant will be assigned to one of the two food groups. Participants in each group will be provided with a daily provision of a chosen sugar-sweetened beverage or savory snack to incorporate into their usual dietary pattern. The main outcome is dietary intake, specifically energy intake gathered by 24 hour dietary recalls. Secondary outcomes include measured body weight / BMI. The participant will be blinded to the main outcome so as not to affect the results. To do this they will be told the rationale for the study is to examine the effect of discretionary food sources on perceived health status and provided a standard, valid short questionnaire (SF-12) at the beginning, middle and end of each period. Investigators will estimate the energy intake necessary for weight maintenance of the subject based upon a standard approach and equation that accounts for the participant's age, sex, body size, and activity level. The subject will be provided with approximately 15-20% of their estimated daily energy needs in the form of a sugar-sweetened beverage or savory snack of their choice during one period and will be asked to incorporate this into their usual dietary pattern each day for 4 weeks. During the 4 week period the subject will be randomly prompted to complete five, 24-hour dietary recalls using an online tool. They will also be asked to fill out a short physical activity questionnaire during the intervention periods and a short questionnaire on perceived health (SF-12). They will have their weight, height, and waist circumference measured at the beginning and end of the period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Savory snack
Arm Type
Experimental
Arm Description
1-2 assigned snacks to be taken in determined portions equivalent to 15% of dietary energy intake, chosen from 9-point hedonic preferences questionnaire completed by participant (chips, pretzels, etc.)
Arm Title
Sugary beverage
Arm Type
Experimental
Arm Description
1-2 soda-based drinks/juice to be taken in determined portions equivalent to 15% of dietary energy intake, chosen from 9-point hedonic preferences questionnaire completed by participant (coke, sprite, etc.)
Intervention Type
Other
Intervention Name(s)
Discretionary calorie source
Intervention Description
We are assigning participants randomly to either of two different sources of discretionary calories (savory snacks or sugary beverages)
Primary Outcome Measure Information:
Title
Dietary energy compensation as measured by weight changes
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults
overweight (BMI ≥ 25 kg/m2)
consume sugar-sweetened beverages or savory snacks
willing to consume amount of beverages and food provided to supplement usual dietary habits during the study period
Exclusion Criteria:
Recently lost a significant amount of weight or looking to lose weight
recently begun a new diet or exercise regimen
prevalent or history of major illnesses or chronic disease (e.g. diabetes, heart disease, cancer, other metabolic disorders) which may affect adherence
pregnant
use of prescription medications (aside from birth control)
report ≥ 1 alcoholic beverage a day
currently smoke
report being a restrained eater or having < 51% of control over the selection and preparation of the food they eat
adults lacking capacity to consent for self
Facility Information:
Facility Name
West Bank Office Building
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23815144
Citation
Almiron-Roig E, Palla L, Guest K, Ricchiuti C, Vint N, Jebb SA, Drewnowski A. Factors that determine energy compensation: a systematic review of preload studies. Nutr Rev. 2013 Jul;71(7):458-73. doi: 10.1111/nure.12048. Epub 2013 Jun 10.
Results Reference
background
PubMed Identifier
16522898
Citation
Popkin BM, Armstrong LE, Bray GM, Caballero B, Frei B, Willett WC. A new proposed guidance system for beverage consumption in the United States. Am J Clin Nutr. 2006 Mar;83(3):529-42. doi: 10.1093/ajcn.83.3.529. Erratum In: Am J Clin Nutr. 2007 Aug;86(2):525.
Results Reference
background
PubMed Identifier
21596051
Citation
Little TJ, Feinle-Bisset C. Effects of dietary fat on appetite and energy intake in health and obesity--oral and gastrointestinal sensory contributions. Physiol Behav. 2011 Sep 26;104(4):613-20. doi: 10.1016/j.physbeh.2011.04.038. Epub 2011 May 3.
Results Reference
background
Citation
Pereira, Mark A. The possible role of sugar-sweetened beverages in obesity etiology: a review of the evidence. Int J Obes. 2006. 30. 28-36.
Results Reference
background
Citation
USDA Dietary Guidelines Advisory Committee. (2005). Discretionary calories. In The Report of the Dietary Guidelines Advisory Committee on Dietary Guidelines for Americans, 2005(6th ed.). United States Department of Agriculture.
Results Reference
background
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Effect on Dietary Compensation and Weight Gain in Adults by Savory Solid and Sugary Liquid Discretionary Food Sources
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