Soda and Milk Study (SAMS)

Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dyslipidemia
• Intervention / Treatment: Dietary supplement: Reduced Fat Milk; Dietary supplement: Sugar Sweetened Soda

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94705
      • Cholesterol Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Fat Milk; 20 oz. reduced fat (2%) milk per day	Dietary supplement: Reduced Fat Milk; Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks; Other Names: 2% milk
Experimental: Sugar Sweetened Soda; 24oz. soda per day	Dietary supplement: Sugar Sweetened Soda; Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks; Other Names: High fructose corn syrup sweetened soda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL peak particle diameter	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma triglycerides		3 weeks
LDL-cholesterol		3 weeks
HDL-cholesterol		3 weeks
Blood pressure	Systolic and diastolic	3 weeks
LDL subclass concentrations		3 weeks
Apolipoprotein B		3 weeks
Apolipoprotein AI		3 weeks
Apolipoprotein CIII		3 weeks

Collaborators and Investigators

• Sponsor: UCSF Benioff Children's Hospital Oakland
• Collaborators: Almond Board of California

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: MM7267