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NCT Number: NCT02094768

Soda and Milk Study

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.

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Key information

Age range

13 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cholesterol Research Center

Berkeley, California, 94705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced Fat Milk

Dietary Supplement

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

Other names: 2% milk

Sugar Sweetened Soda

Dietary Supplement

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

Other names: High fructose corn syrup sweetened soda

Primary outcomes

  1. LDL peak particle diameter

    Time frame: 3 weeks

Secondary outcomes

  1. Plasma triglycerides

    Time frame: 3 weeks

  2. LDL-cholesterol

    Time frame: 3 weeks

  3. HDL-cholesterol

    Time frame: 3 weeks

  4. Blood pressure

    Time frame: 3 weeks

    Systolic and diastolic

  5. LDL subclass concentrations

    Time frame: 3 weeks

  6. Apolipoprotein B

    Time frame: 3 weeks

  7. Apolipoprotein AI

    Time frame: 3 weeks

  8. Apolipoprotein CIII

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Acronym: SAMS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 24, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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