Effect on Dietary Compensation and Weight Gain in Adults by Savory Solid and Sugary Liquid Discretionary Food Sources

NCT02564874 | Withdrawn

• 1 other identifier: 1505M71543
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

• Dietary energy compensation as measured by weight changes

  4 weeks

Study Arms (2)

Savory snack

EXPERIMENTAL

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.)

Other: Discretionary calorie source

Sugary beverage

EXPERIMENTAL

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.)

Other: Discretionary calorie source

Interventions

Discretionary calorie source OTHER

We are assigning participants randomly to either of two different sources of discretionary calories (savory snacks or sugary beverages)

Savory snack; Sugary beverage

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

West Bank Office Building

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (5)

• 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.

  PMID: 23815144 BACKGROUND

• 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.

  PMID: 16522898 BACKGROUND

• 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.

  PMID: 21596051 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

US (1)