Metabolic Syndrome Clinical Trial
— OASISOfficial 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
NCT number | NCT03527277 |
Other study ID # | 1167030 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | May 28, 2023 |
Verified date | June 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 28, 2023 |
Est. primary completion date | May 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Touro University, California |
United States,
Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin — View Citation
Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gluconeogenesis | Determined from glucose isotopomer distribution | 4 weeks | |
Other | Glycogenolysis | Endogenous glucose production minus gluconeogenesis | 4 weeks | |
Other | Lipolysis | Determined from glycerol isotopomer distribution | 4 weeks | |
Other | Triglyceride production | Determined from glycerol isotopomer distribution | 4 weeks | |
Other | Energy expenditure | Postprandial energy expenditure | 4 weeks | |
Other | Fat oxidation | Postprandial fat oxidation | 4 weeks | |
Other | Hesperetin-7-O-glucuronide | Urine concentration hesperetin-7-O-glucuronide | 4 weeks | |
Other | Naringenin-4'-O-glucuronide | Urine concentration naringenin-4'-O-glucuronide | 4 weeks | |
Other | Naringen-7-O-glucuronide | Urine concentration naringen-7-O-glucuronide | 4 weeks | |
Other | Fecal microbiota | Fecal relative bacterial abundance | 4 weeks | |
Other | Insulin | fasting and postprandial plasma insulin concentration | 4 week | |
Other | glucose | fasting and postprandial plasma glucose concentration | glucose | |
Other | Apolipoprotein E (apoE) | plasma apoE concentration | 4 weeks | |
Other | high sensitivity C reactive protein (CRP) | plasma CRP concentration | 4 weeks | |
Other | aspartate aminotransferase (AST) | plasma AST concentration | 4 weeks | |
Other | alanine aminotransferase (ALT) | plasma ALT concentration | 4 weeks | |
Other | gamma-glutamyl transferase (GGT) | plasma GGT concentration | 4 weeks | |
Other | oxidized LDL (oxLDL) | plasma oxLDL concentration | 4 weeks | |
Other | malondialdehyde | fasting and postprandial plasma malondialdehyde concentration | 4 weeks | |
Other | total antioxidant status | fasting and postprandial plasma total antioxidant status | 4 weeks | |
Other | soluble vascular cellular adhesion molecule (sVCAM-1) | plasma sVCAM-1 concentration | 4 weeks | |
Other | monocyte chemotactic protein-1 (MCP-1) | plasma MCP-1 concentration | 4 weeks | |
Other | nitric oxide metabolite (NOx) | plasma NOx concentration | 4 weeks | |
Other | Diastolic and systolic blood pressure | fasting and postprandial blood pressure | 4 weeks | |
Other | Body fat | %body fat | 4 weeks | |
Other | Visceral fat | Abdominal visceral fat volume | 4 weeks | |
Other | Subcutaneous fat | Abdominal subcutaneous fat volume | 4 weeks | |
Other | Physical activity | Assessed by accelerometer | 4 weeks | |
Other | Eating motivation | 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) | 4 weeks | |
Primary | Low density lipoprotein cholesterol (LDL-C) | Plasma LDL-C concentration | 4 weeks | |
Primary | Apolipoprotein B (apoB) | Plasma apoB concentration | 4 weeks | |
Primary | Uric acid | Plasma uric acid concentration | 4 weeks | |
Primary | de novo lipogenesis (DNL) | %Fractional rate DNL | 4 weeks | |
Primary | Hepatic triglyceride | %hepatic triglyceride | 4 weeks | |
Primary | Endogenous glucose production | Endogenous glucose production during hyperinsulinemic clamp | 4 weeks | |
Secondary | Postprandial triglyceride | Plasma postprandial triglyceride concentration | 4 weeks | |
Secondary | 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic | Urine concentration of 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic | 4 weeks | |
Secondary | hesperetin-3'-O-glucuronide | Urine concentration hesperetin-3'-O-glucuronide | 4 weeks | |
Secondary | hesperetin-3'-sulfate | Urine concentration hesperetin-3'-sulfate | 4 weeks | |
Secondary | Apolipoprotein CIII (apoCIII) | Fasting and postprandial plasma apoCIII concentration | 4 weeks | |
Secondary | non-high density lipoprotein cholesterol (non-HDL-C) | Plasma non-HDL-C concentration | 4 weeks |
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