Soda and Milk Study (SAMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital & Research Center Oakland
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT02094768
First received: March 20, 2014
Last updated: May 21, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents

Resource links provided by NLM:


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

Primary Outcome Measures:
  • LDL peak particle diameter [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma triglycerides [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Systolic and diastolic

  • LDL subclass concentrations [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein CIII [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   13 Years to 18 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094768

Contacts
Contact: Megan Bennett 510-665-0500 crcinfo@chori.org

Locations
United States, California
Cholesterol Research Center Recruiting
Berkeley, California, United States, 94705
Contact: Megan Bennett    510-665-0500    mbennett@chori.org   
Principal Investigator: Ronald M Krauss, MD         
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

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT02094768     History of Changes
Other Study ID Numbers: MM7267
Study First Received: March 20, 2014
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014