Orange Juice And Sugar Intervention Study

NCT03527277 | Completed Results

• 2 other identifiers: 1167030R01HL137716
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Type2 Diabetes Mellitus; Insulin Sensitivity; Metabolic Syndrome

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

Outcome Measures

Primary Outcomes (13)

• Fasting Low Density Lipoprotein Cholesterol (LDL-C)

  Absolute change of plasma LDL-C concentration (4 week value - 0 week value)

  4 weeks

• Postprandial Low Density Lipoprotein Cholesterol (LDL-C)

  Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value)

  4 weeks

• Fasting Apolipoprotein B (apoB)

  Absolute change of plasma apoB concentration (4 week value - 0 week value)

  4 weeks

• Postprandial Apolipoprotein B (apoB)

  Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value)

  4 weeks

• Fasting Uric Acid

  Absolute change of plasma uric acid concentration (4 week value - 0 week value)

  4 weeks

• Postprandial Uric Acid

  Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value)

  4 weeks

• Fasting Apolipoprotein CIII (apoCIII)

  Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value)

  4 weeks

• Postprandial Apolipoprotein CIII (apoCIII)

  Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)

  4 weeks

• Postprandial Triglyceride

  Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value)

  4 weeks

• Hepatic Triglyceride

  Absolute change of % hepatic triglyceride (4 week value - 0 week value)

  4 weeks

• Matsuda Insulin Sensitivity Index (ISI)

  Absolute change of Matsuda ISI (4 week value - 0 week value). The Matsuda Index is a ratio of glucose and insulin levels during oral glucose tolerance test. It is calculated using fasting and mean glucose and insulin measurements, but the units of these measurements cancel out in the formula. A Matsuda value less than 2.5 may indicate insulin resistance, thus a lowering of the Matsuda index is a detrimental outcome. At baseline the Matsuda index in the participants for which it was assessed ranged from 1.4 to 7.8 (mean = 3.7, standard deviation = 1.6).

  4 week

• Postprandial de Novo Lipogenesis

  Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value)

  4 weeks

• M Value During Hyperinsulinemic Euglycemic Clamp

  Absolute change of M value (glucose infusion rate during final 30 minute steady state)/ fat free body mass (kg) (4 week value - 0 week value)

  4 weeks

Secondary Outcomes (11)

• Fasting Triglyceride

  4 weeks

• 3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic

  4 weeks

• Hesperetin-3'-O-glucuronide

  4 weeks

• Hesperetin-3',7-0-diglucuronide

  4 weeks

• p-Hydroxyhippuric Acid

  4 weeks

Other Outcomes (6)

• Fasting Insulin

  4 week

• Fasting Glucose

  glucose

• Body Weight

  4 weeks

Study Arms (2)

Naturally-sweetened orange juice

EXPERIMENTAL

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

Sugar-sweetened beverage

ACTIVE COMPARATOR

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

Interventions

Naturally-sweetened orange juice OTHER

Commercially-available ready-to-serve refrigerated orange juice

Naturally-sweetened orange juice

Sugar-sweetened beverage OTHER

Sugar-sweetened water flavored with Kool-Aid (TM)

Sugar-sweetened beverage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: self-representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Touro University, California: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Related Publications (2)

• 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.

  PMID: 24493081 RESULT

• 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 Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22.

  PMID: 25904601 RESULT

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Interventions

Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

It is a limitation of the trial that we did not achieve the diversity of race/ethnicity that we had planned. Due to the COVID epidemic most of our participants were University of California Davis students. Thus our demographics reflect the UC Davis student population and 63% of the participants were Asian.

Results Point of Contact

• Title: Kimber Stanhope
• Organization: University of California, Davis

klstanhope@ucdavis.edu

5302190914

Study Officials

• Kimber L Stanhope, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes will be analyzed/assessed by subject identity number, which are assigned prior to randomization to experimental arm.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nutritional Biologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 17, 2018
• Study Start: June 1, 2018
• Primary Completion: May 28, 2023
• Study Completion: May 28, 2023
• Last Updated: November 10, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after the end of study--January 31, 2025
• 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.

Locations

US (1)