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



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 59
Updated:4/21/2016
Start Date:June 2015
Contact:Diksha Srishyla
Email:srish001@umn.edu
Phone:(612)607-4922

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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.

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.

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
We found this trial at
1
site
1300 13th Avenue South
Minneapolis, Minnesota 55454
Phone: 612-624-4173
?
mi
from
Minneapolis, MN
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