Orange Juice And Sugar Intervention Study
Condition: Cardiovascular Risk Factor; Type2 Diabetes Mellitus; Insulin Sensitivity; Metabolic Syndrome
MeSH terms: Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The objectives of this proposal are to address the gaps in knowledge regarding the metabolic
      effects of consuming orange juice, the most frequently consumed fruit juice in this country,
      compared to sugar-sweetened beverage.
    

Detailed description: 
      Specific Aims: There is considerable epidemiological evidence that demonstrates associations
      between added sugar/sugar-sweetened beverage consumption and increased risk for or prevalence
      of chronic diseases such as cardiovascular disease (CVD), type 2 diabetes (T2D), metabolic
      syndrome, and gout. Especially concerning is recent evidence from National Health and
      Nutrition Examination Survey III that demonstrates that there is increased risk of CVD
      mortality with increased intake of added sugar across quintiles (Yang, 2014). Even the US
      mean added sugar intake, 15% of daily calories, was associated with an 18% increase in risk
      of CVD mortality over 15 years. The results from the investigator's recently completed study
      (1R01 HL09133) corroborate these findings (Stanhope, 2015). They demonstrate that
      supplementing the ad libitum diets of young adults with beverages containing 0, 10, 17.5 or
      25% of daily energy requirement (Ereq) as high fructose corn syrup (HFCS) affects
      lipid/lipoprotein risk factors for CVD in a dose response manner. Specifically, levels of
      nonHDL-cholesterol(C), LDL-C, apolipoprotein B (apoB), and postprandial triglycerides (TG)
      increased linearly over a 2-week period with increasing doses of HFCS. Furthermore, even the
      participants consuming the 10% Ereq dose exhibited increased levels of these risk factors
      compared to baseline.

      These and similar results have helped to lead to reductions in soda consumption in this
      country, and new dietary guidelines and FDA food labeling requirements to promote reductions
      in added sugar consumption. However, there are gaps in knowledge about other sugar-containing
      foods that lead to public confusion concerning healthier options for soda, and impede further
      progress in implementing public health policies that will promote further reductions in soda
      consumption. One such food is naturally-sweetened fruit juice. The amount of sugar in fruit
      juice is comparable to the amount in soda. Because of this, a consumer seeking answers on the
      internet will find many articles in which experts state or suggest that the effects of
      consuming fruit juice are as detrimental as or even worse than those of soda. However, in
      contrast to soda, fruit juice contains micronutrients and bioactives that may promote health.
      Therefore the consumer can also find numerous articles on the internet where the health
      benefits of fruit juice and these bioactives are extolled. There are a limited number of
      clinical dietary intervention studies that have directly compared the metabolic effects of
      consuming fruit juice and sugar-sweetened beverage, and their results are not conclusive.
      Thus we will pursue the following Specific Aims:

        1. Specific Aim 1: To compare the weight-independent effects of consuming 25%Ereq as orange
           juice or sugar-sweetened beverages for 4 weeks on risk factors for CVD and other chronic
           disease in normal weight and overweight men and women.

        2. Specific Aim 2: To mechanistically compare the weight-independent effects of consuming
           25%Ereq as orange juice or sugar-sweetened beverages on metabolic processes associated
           with the development of CVD and T2D in normal weight and overweight men and women.

        3. Specific Aim 3: To relate the changes assessed under Specific Aims 1 and 2 to the
           changes in the urinary levels of metabolites and catabolites of the main flavanones in
           orange juice, hesperetin and naringenin.
    

Intervention name(s): Naturally-sweetened orange juice; Sugar-sweetened beverage
Intervention type(s): Other; Other
Intervention description(s): Commercially-available ready-to-serve refrigerated orange juice; Sugar-sweetened water flavored with Kool-Aid (TM)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: orange juice; sugar-sweetened beverage; triglyceride; low density lipoprotein cholesterol; apolipoprotein B; uric acid; de novo lipogenesis; hepatic triglyceride; hepatic glucose production; whole body insulin sensitivity