Clinical trial NCT02094768: Soda and Milk Study
Official title: Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dyslipidemia
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2014-03-24
Enrollment: 30
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: LDL peak particle diameter
timeFrame: 3 weeks
Secondary outcomes:
measure: Plasma triglycerides
timeFrame: 3 weeks
measure: LDL-cholesterol
timeFrame: 3 weeks
measure: HDL-cholesterol
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
measure: LDL subclass concentrations
timeFrame: 3 weeks
measure: Apolipoprotein B
timeFrame: 3 weeks
measure: Apolipoprotein AI
timeFrame: 3 weeks
measure: Apolipoprotein CIII
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Cholesterol Research Center
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ronald M Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References: