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Soda and Milk Study

Rakstu tulkošanu var veikt tikai reģistrēti lietotāji
Ielogoties Reģistrēties
Saite tiek saglabāta starpliktuvē
StatussPabeigts
Sponsori
UCSF Benioff Children's Hospital Oakland
Līdzstrādnieki
Almond Board of California

Atslēgvārdi

Abstrakts

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.

Datumi

Pēdējoreiz pārbaudīts: 09/30/2017
Pirmais iesniegtais: 03/19/2014
Paredzētā reģistrācija iesniegta: 03/20/2014
Pirmais izlikts: 03/23/2014
Pēdējais atjauninājums iesniegts: 10/30/2017
Pēdējā atjaunināšana ievietota: 11/05/2017
Faktiskais studiju sākuma datums: 03/31/2014
Paredzamais primārās pabeigšanas datums: 08/31/2016
Paredzamais pētījuma pabeigšanas datums: 04/30/2017

Stāvoklis vai slimība

Obesity
Dyslipidemia

Iejaukšanās / ārstēšana

Dietary Supplement: Reduced Fat Milk

Dietary Supplement: Sugar Sweetened Soda

Fāze

-

Roku grupas

RokaIejaukšanās / ārstēšana
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

Atbilstības kritēriji

Vecums, kas piemērots studijām 13 Years Uz 13 Years
Dzimumi, kas ir piemēroti studijāmMale
Pieņem veselīgus brīvprātīgos
Kritēriji

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

Rezultāts

Primārie rezultāti

1. LDL peak particle diameter [3 weeks]

Sekundārie iznākuma mērījumi

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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