Soda and Milk Study (SAMS)
Primary Purpose
Obesity, Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced Fat Milk
Sugar Sweetened Soda
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Males, age 13-18
- Tanner stage ≥ 2
- Self reported sugar sweetened beverage intake 24oz to 60oz per day
- Self reported milk intake ≤16 oz. per day
- BMI 85-99 percentile for age
- Tolerant to milk
Exclusion Criteria:
- History or diagnosis of hypertension or taking blood pressure lowering medication
- History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
- Fasting triglyceride > 300 mg/dl
- On lipid lowering or diabetes medication
Sites / Locations
- Cholesterol Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Reduced Fat Milk
Sugar Sweetened Soda
Arm Description
20 oz. reduced fat (2%) milk per day
24oz. soda per day
Outcomes
Primary Outcome Measures
LDL peak particle diameter
Secondary Outcome Measures
Plasma triglycerides
LDL-cholesterol
HDL-cholesterol
Blood pressure
Systolic and diastolic
LDL subclass concentrations
Apolipoprotein B
Apolipoprotein AI
Apolipoprotein CIII
Full Information
NCT ID
NCT02094768
First Posted
March 20, 2014
Last Updated
October 31, 2017
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Almond Board of California
1. Study Identification
Unique Protocol Identification Number
NCT02094768
Brief Title
Soda and Milk Study
Acronym
SAMS
Official Title
Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Almond Board of California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reduced Fat Milk
Arm Type
Experimental
Arm Description
20 oz. reduced fat (2%) milk per day
Arm Title
Sugar Sweetened Soda
Arm Type
Experimental
Arm Description
24oz. soda per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Reduced Fat Milk
Other Intervention Name(s)
2% milk
Intervention Description
Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar Sweetened Soda
Other Intervention Name(s)
High fructose corn syrup sweetened soda
Intervention Description
Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks
Primary Outcome Measure Information:
Title
LDL peak particle diameter
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Plasma triglycerides
Time Frame
3 weeks
Title
LDL-cholesterol
Time Frame
3 weeks
Title
HDL-cholesterol
Time Frame
3 weeks
Title
Blood pressure
Description
Systolic and diastolic
Time Frame
3 weeks
Title
LDL subclass concentrations
Time Frame
3 weeks
Title
Apolipoprotein B
Time Frame
3 weeks
Title
Apolipoprotein AI
Time Frame
3 weeks
Title
Apolipoprotein CIII
Time Frame
3 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males, age 13-18
Tanner stage ≥ 2
Self reported sugar sweetened beverage intake 24oz to 60oz per day
Self reported milk intake ≤16 oz. per day
BMI 85-99 percentile for age
Tolerant to milk
Exclusion Criteria:
History or diagnosis of hypertension or taking blood pressure lowering medication
History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
Fasting triglyceride > 300 mg/dl
On lipid lowering or diabetes medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
12. IPD Sharing Statement
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Soda and Milk Study
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