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

April 21, 2017 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • West Bank Office Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Savory snack
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
We are assigning participants randomly to either of two different sources of discretionary calories (savory snacks or sugary beverages)
Experimental: Sugary beverage
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
We are assigning participants randomly to either of two different sources of discretionary calories (savory snacks or sugary beverages)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dietary energy compensation as measured by weight changes
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1505M71543

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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