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Soda and Milk Study (SAMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02094768
First Posted: March 24, 2014
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
  Purpose
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.

Condition Intervention
Obesity Dyslipidemia Dietary Supplement: Reduced Fat Milk Dietary Supplement: Sugar Sweetened Soda

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • LDL peak particle diameter [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Plasma triglycerides [ Time Frame: 3 weeks ]
  • LDL-cholesterol [ Time Frame: 3 weeks ]
  • HDL-cholesterol [ Time Frame: 3 weeks ]
  • Blood pressure [ Time Frame: 3 weeks ]
    Systolic and diastolic

  • LDL subclass concentrations [ Time Frame: 3 weeks ]
  • Apolipoprotein B [ Time Frame: 3 weeks ]
  • Apolipoprotein AI [ Time Frame: 3 weeks ]
  • Apolipoprotein CIII [ Time Frame: 3 weeks ]

Enrollment: 30
Actual Study Start Date: April 2014
Study Completion Date: May 2017
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced Fat Milk
20 oz. reduced fat (2%) milk per day
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
Other Name: 2% milk
Experimental: Sugar Sweetened Soda
24oz. soda per day
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
Other Name: High fructose corn syrup sweetened soda

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094768


Locations
United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Almond Board of California
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT02094768     History of Changes
Other Study ID Numbers: MM7267
First Submitted: March 20, 2014
First Posted: March 24, 2014
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases