Soda and Milk Study

Not Applicable

Completed

• Conditions: Obesity; Dyslipidemia
• Interventions: Dietary Supplement: Reduced Fat Milk; Dietary Supplement: Sugar Sweetened Soda

• Registration Number: NCT02094768
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-24
• Study Start: 2014-04
• Primary Completion: 2016-09
• Study Completion: 2017-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reduced Fat Milk	Reduced Fat Milk	20 oz. reduced fat (2%) milk per day
Sugar Sweetened Soda	Sugar Sweetened Soda	24oz. soda per day

Primary Outcome Measures

Name	Time	Method
LDL peak particle diameter	3 weeks

Secondary Outcome Measures

Name	Time	Method
LDL subclass concentrations	3 weeks
Apolipoprotein B	3 weeks
Apolipoprotein AI	3 weeks
Apolipoprotein CIII	3 weeks
Plasma triglycerides	3 weeks
LDL-cholesterol	3 weeks
HDL-cholesterol	3 weeks
Blood pressure	3 weeks	Systolic and diastolic

Trial Locations

Locations (1)

Cholesterol Research Center; 🇺🇸 Berkeley, California, United States