Orange Juice And Sugar Intervention Study

Metabolic Syndrome Clinical Trial

— OASIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527277
• Other study ID #: 1167030
• Status: Completed
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Metabolic Syndrome
• Type2 Diabetes Mellitus

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

External Links

•   Learn more or sign up for the study here!