The Potentially Addictive Properties of Soda: A Feasibility Study

December 8, 2014 updated by: University of California, Berkeley
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • 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
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital and Reasearch Center Oakland

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

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Drinks more than 36 ounces of sugar-sweetened beverages per day
  • Speaks fluent English
  • Parent speaks English or Spanish
  • Lives in San Francisco Bay Area

Exclusion Criteria:

  • Pregnant or nursing
  • Taking medication to address mental health issues

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSB withdrawal
Behavioral: SSB withdrawal
During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of withdrawal
Time Frame: Days 1-3 and days 6-8
Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being.
Days 1-3 and days 6-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diet
Time Frame: Days 1-2, 6-8
Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls
Days 1-2, 6-8
Change in impulsivity
Time Frame: Days 1 and 8
Impulsivity will be assessed via the delayed discounting task
Days 1 and 8
Change in stress
Time Frame: Days 1 and 8
Stress will be assessed via salivary cortisol samples
Days 1 and 8
Change in preference for soda
Time Frame: Days 1-3, 6-8
Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions
Days 1-3, 6-8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase
Time Frame: Days 6-8
Using measure of salivary caffeine, beverage recalls, and 24-hour dietary recalls, we will assess compliance.
Days 6-8

Collaborators and Investigators

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

Sponsor

University of California, Berkeley

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Kristine A Madsen, MD, MPH, University of California, Berkeley School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-08545
  • 6030sc (Other Grant/Funding Number: UC Office of the President)

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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