Soda and Milk Study

NCT02094768 | Completed

• 1 other identifier: MM7267
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• LDL peak particle diameter

  3 weeks

Secondary Outcomes (8)

• Plasma triglycerides

  3 weeks

• LDL-cholesterol

  3 weeks

• HDL-cholesterol

  3 weeks

• Blood pressure

  3 weeks

• LDL subclass concentrations

  3 weeks

Study Arms (2)

Reduced Fat Milk

EXPERIMENTAL

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

Dietary Supplement: Reduced Fat Milk

Sugar Sweetened Soda

EXPERIMENTAL

24oz. soda per day

Dietary Supplement: Sugar Sweetened Soda

Interventions

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

Also known as: 2% milk

Reduced Fat 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

Also known as: High fructose corn syrup sweetened soda

Sugar Sweetened Soda

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• Almond Board of California: collaborator

Study Sites (1)

Cholesterol Research Center

Berkeley, California, 94705, United States

Location

MeSH Terms

Conditions

Obesity; Dyslipidemias

Interventions

Diet, Fat-Restricted; Milk; Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Beverages; Dairy Products; Food; Food and Beverages

Study Officials

• Ronald M Krauss, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

US (1)