The Potentially Addictive Properties of Soda: A Feasibility Study

Withdrawal Symptoms Clinical Trial

Official title:

The Potentially Addictive Properties of Soda: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044757
• Other study ID #: 12-08545
• Secondary ID: 6030sc
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: December 8, 2014
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Withdrawal Symptoms

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital and Reasearch Center Oakland	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase	Using measure of salivary caffeine, beverage recalls, and 24-hour dietary recalls, we will assess compliance.	Days 6-8	No
Primary	Symptoms of withdrawal	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	No
Secondary	Change in diet	Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls	Days 1-2, 6-8	No
Secondary	Change in impulsivity	Impulsivity will be assessed via the delayed discounting task	Days 1 and 8	No
Secondary	Change in stress	Stress will be assessed via salivary cortisol samples	Days 1 and 8	No
Secondary	Change in preference for soda	Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions	Days 1-3, 6-8	No