Soda and Milk Study

NCT ID: NCT02094768

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Obesity; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Reduced Fat Milk

20 oz. reduced fat (2%) milk per day

Group Type: EXPERIMENTAL

Reduced Fat Milk

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks

Sugar Sweetened Soda

24oz. soda per day

Group Type: EXPERIMENTAL

Sugar Sweetened Soda

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Reduced Fat Milk

Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

2% milk; High fructose corn syrup sweetened soda

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M Krauss, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

Cholesterol Research Center

Berkeley, California, United States

Countries

United States

Other Identifiers

MM7267

Identifier Type: -

Identifier Source: org_study_id