Soda and Milk Study



Status:Active, not recruiting
Conditions:High Cholesterol, Obesity Weight Loss
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:13 - 18
Updated:2/16/2017
Start Date:April 2014
End Date:May 2017

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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.


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
We found this trial at
1
site
Berkeley, California 94705
Principal Investigator: Ronald M Krauss, MD
Phone: 510-665-0500
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mi
from
Berkeley, CA
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