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Soda and Milk Study

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赞助商
UCSF Benioff Children's Hospital Oakland
合作者
Almond Board of California

关键词

抽象

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.

日期

最后验证: 09/30/2017
首次提交: 03/19/2014
提交的预估入学人数: 03/20/2014
首次发布: 03/23/2014
上次提交的更新: 10/30/2017
最近更新发布: 11/05/2017
实际学习开始日期: 03/31/2014
预计主要完成日期: 08/31/2016
预计完成日期: 04/30/2017

状况或疾病

Obesity
Dyslipidemia

干预/治疗

Dietary Supplement: Reduced Fat Milk

Dietary Supplement: Sugar Sweetened Soda

-

手臂组

干预/治疗
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
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

资格标准

有资格学习的年龄 13 Years 至 13 Years
有资格学习的性别Male
接受健康志愿者
标准

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

结果

主要结果指标

1. LDL peak particle diameter [3 weeks]

次要成果指标

1. Plasma triglycerides [3 weeks]

2. LDL-cholesterol [3 weeks]

3. HDL-cholesterol [3 weeks]

4. Blood pressure [3 weeks]

Systolic and diastolic

5. LDL subclass concentrations [3 weeks]

6. Apolipoprotein B [3 weeks]

7. Apolipoprotein AI [3 weeks]

8. Apolipoprotein CIII [3 weeks]

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