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Orange Juice And Sugar Intervention Study (OASIS)

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ClinicalTrials.gov Identifier: NCT03527277
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Touro University, California
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Type2 Diabetes Mellitus Insulin Sensitivity Metabolic Syndrome Other: Naturally-sweetened orange juice Other: Sugar-sweetened beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: All outcomes will be analyzed/assessed by subject identity number, which are assigned prior to randomization to experimental arm.
Primary Purpose: Basic Science
Official Title: The Effects of Orange Juice Compared With Sugar-sweetened Beverage on Risk Factors and Metabolic Processes Associated With the Development of Cardiovascular Disease and Type 2 Diabetes
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naturally-sweetened orange juice
Naturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks
Other: Naturally-sweetened orange juice
Commercially-available ready-to-serve refrigerated orange juice

Active Comparator: Sugar-sweetened beverage
Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks
Other: Sugar-sweetened beverage
Sugar-sweetened water flavored with Kool-Aid (TM)




Primary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: 4 weeks ]
    Plasma LDL-C concentration

  2. Apolipoprotein B (apoB) [ Time Frame: 4 weeks ]
    Plasma apoB concentration

  3. Uric acid [ Time Frame: 4 weeks ]
    Plasma uric acid concentration

  4. de novo lipogenesis (DNL) [ Time Frame: 4 weeks ]
    %Fractional rate DNL

  5. Hepatic triglyceride [ Time Frame: 4 weeks ]
    %hepatic triglyceride

  6. Endogenous glucose production [ Time Frame: 4 weeks ]
    Endogenous glucose production during hyperinsulinemic clamp


Secondary Outcome Measures :
  1. Postprandial triglyceride [ Time Frame: 4 weeks ]
    Plasma postprandial triglyceride concentration

  2. 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic [ Time Frame: 4 weeks ]
    Urine concentration of 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic

  3. hesperetin-3'-O-glucuronide [ Time Frame: 4 weeks ]
    Urine concentration hesperetin-3'-O-glucuronide

  4. hesperetin-3'-sulfate [ Time Frame: 4 weeks ]
    Urine concentration hesperetin-3'-sulfate

  5. Apolipoprotein CIII (apoCIII) [ Time Frame: 4 weeks ]
    Fasting and postprandial plasma apoCIII concentration

  6. non-high density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 4 weeks ]
    Plasma non-HDL-C concentration


Other Outcome Measures:
  1. Gluconeogenesis [ Time Frame: 4 weeks ]
    Determined from glucose isotopomer distribution

  2. Glycogenolysis [ Time Frame: 4 weeks ]
    Endogenous glucose production minus gluconeogenesis

  3. Lipolysis [ Time Frame: 4 weeks ]
    Determined from glycerol isotopomer distribution

  4. Triglyceride production [ Time Frame: 4 weeks ]
    Determined from glycerol isotopomer distribution

  5. Energy expenditure [ Time Frame: 4 weeks ]
    Postprandial energy expenditure

  6. Fat oxidation [ Time Frame: 4 weeks ]
    Postprandial fat oxidation

  7. Hesperetin-7-O-glucuronide [ Time Frame: 4 weeks ]
    Urine concentration hesperetin-7-O-glucuronide

  8. Naringenin-4'-O-glucuronide [ Time Frame: 4 weeks ]
    Urine concentration naringenin-4'-O-glucuronide

  9. Naringen-7-O-glucuronide [ Time Frame: 4 weeks ]
    Urine concentration naringen-7-O-glucuronide

  10. Fecal microbiota [ Time Frame: 4 weeks ]
    Fecal relative bacterial abundance

  11. Insulin [ Time Frame: 4 week ]
    fasting and postprandial plasma insulin concentration

  12. glucose [ Time Frame: glucose ]
    fasting and postprandial plasma glucose concentration

  13. Apolipoprotein E (apoE) [ Time Frame: 4 weeks ]
    plasma apoE concentration

  14. high sensitivity C reactive protein (CRP) [ Time Frame: 4 weeks ]
    plasma CRP concentration

  15. aspartate aminotransferase (AST) [ Time Frame: 4 weeks ]
    plasma AST concentration

  16. alanine aminotransferase (ALT) [ Time Frame: 4 weeks ]
    plasma ALT concentration

  17. gamma-glutamyl transferase (GGT) [ Time Frame: 4 weeks ]
    plasma GGT concentration

  18. oxidized LDL (oxLDL) [ Time Frame: 4 weeks ]
    plasma oxLDL concentration

  19. malondialdehyde [ Time Frame: 4 weeks ]
    fasting and postprandial plasma malondialdehyde concentration

  20. total antioxidant status [ Time Frame: 4 weeks ]
    fasting and postprandial plasma total antioxidant status

  21. soluble vascular cellular adhesion molecule (sVCAM-1) [ Time Frame: 4 weeks ]
    plasma sVCAM-1 concentration

  22. monocyte chemotactic protein-1 (MCP-1) [ Time Frame: 4 weeks ]
    plasma MCP-1 concentration

  23. nitric oxide metabolite (NOx) [ Time Frame: 4 weeks ]
    plasma NOx concentration

  24. Diastolic and systolic blood pressure [ Time Frame: 4 weeks ]
    fasting and postprandial blood pressure

  25. Body fat [ Time Frame: 4 weeks ]
    %body fat

  26. Visceral fat [ Time Frame: 4 weeks ]
    Abdominal visceral fat volume

  27. Subcutaneous fat [ Time Frame: 4 weeks ]
    Abdominal subcutaneous fat volume

  28. Physical activity [ Time Frame: 4 weeks ]
    Assessed by accelerometer

  29. Eating motivation [ Time Frame: 4 weeks ]
    Assessed by 19 questions that are scored on a 5-point scale with 5 describing eating behavior driven by reasons other than hunger (i.e. emotions, social pressure)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: men and pre-menopausal women Body mass index: 20-35 kg/m2 Body weight > than 50 kg Self-reported stable body weight during the prior six months

Exclusion Criteria:

Fasting glucose >125 mg/dl Evidence of liver disorder (AST or ALT >200% upper limit of normal range) Evidence of kidney disorder (>2.0 mg/dl creatinine) Evidence of thyroid disorder (out of normal range) Systolic blood pressure consistently over 140 mmHg or diastolic blood pressure over 90 mmHg Triglycerides > 400 mg/dl LDL-C > 160 mg/dl in combination with Chol:HDL > 4 Hemoglobin < 10 g/dL Pregnant or lactating women Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents.

Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results Use of tobacco Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking) Surgery for weight loss Diet exclusions: Food allergies, special dietary restrictions, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu Veins that are assessed by the R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter.

Pre-existing claustrophobia or metal implants that preclude magnetic resonance imaging Any other condition that, in the opinion of the investigators, would put the subject at risk

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527277


Contacts
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Contact: Kimber L Stanhope, Ph.D. 530-219-0914 klstanhope@ucdavis.edu
Contact: Vivien Lee, B.S. 530-752-2714 vilee@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Kimber Stanhope, Ph.D.    530-752-3720    klstanhope@ucdavis.edu   
Contact: Vivien Lee, B.S.    530-752-2714    vilee@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Touro University, California
Investigators
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Principal Investigator: Kimber L Stanhope, Ph.D. University of California, Davis

Publications of Results:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03527277     History of Changes
Other Study ID Numbers: 1167030
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final dataset will include data collected specifically for the study and data provided during screening in the medical history form. This includes some demographic information and data regarding family history of disease. We will make data and demographic information available to other investigators upon request. The dataset will be stripped of all unique identifiers and subject characteristics and prepared in accordance with all HIPAA regulations prior to release for sharing. Study outcome results will be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One year after the end of study--March 31, 2024
Access Criteria:

We will make data and demographic information available to investigators who submit an outline with:

  1. Hypotheses/aims
  2. Assurance that the data will be stored on secured computer
  3. Assurance that access will be limited to those named in the proposal
  4. Commitment to destroy/return the data after analyses are completed
  5. Guarantee that the grant and the primary investigators will be acknowledged in any publications arising from these data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Metabolic Syndrome
Insulin Resistance
Hypersensitivity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Immune System Diseases