Soda and Milk Study

Obesity Clinical Trial

— SAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094768
• Other study ID #: MM7267
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: October 31, 2017
• Start date: April 2014
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

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
• Sugar Sweetened Soda
Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks

Locations

Country	Name	City	State
United States	Cholesterol Research Center	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL peak particle diameter		3 weeks
Secondary	Plasma triglycerides		3 weeks
Secondary	LDL-cholesterol		3 weeks
Secondary	HDL-cholesterol		3 weeks
Secondary	Blood pressure	Systolic and diastolic	3 weeks
Secondary	LDL subclass concentrations		3 weeks
Secondary	Apolipoprotein B		3 weeks
Secondary	Apolipoprotein AI		3 weeks
Secondary	Apolipoprotein CIII		3 weeks