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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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 -

Study Design


Intervention

Other:
Naturally-sweetened orange juice
Commercially-available ready-to-serve refrigerated orange juice
Sugar-sweetened beverage
Sugar-sweetened water flavored with Kool-Aid (TM)

Locations

Country Name City State
United States University of California, Davis Davis California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis Touro University, California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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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