N/A N=56 Randomized Single-blind Basic Science

Orange Juice And Sugar Intervention Study

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

Bottom Line

View on ClinicalTrials.gov: NCT03527277 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Fasting Low Density Lipoprotein Cholesterol (LDL-C) — 5.5; 5.8 mg/dl — p=0.88

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Naturally-sweetened orange juice (Other); Sugar-sweetened beverage (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of California, Davis
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Low Density Lipoprotein Cholesterol (LDL-C)	5.5; 5.8	0.88
PRIMARY Postprandial Low Density Lipoprotein Cholesterol (LDL-C)	5.9; 6.7	0.65
PRIMARY Fasting Apolipoprotein B (apoB)	2.9; 3.4	0.92
PRIMARY Postprandial Apolipoprotein B (apoB)	3.7; 4.3	0.81
PRIMARY Fasting Uric Acid	-0.92; 0.11	<0.0001 sig
PRIMARY Postprandial Uric Acid	-3.3; 0.40	<0.0001 sig
PRIMARY Fasting Apolipoprotein CIII (apoCIII)	0.40; 0.60	0.42
PRIMARY Postprandial Apolipoprotein CIII (apoCIII)	0.64; 0.38	0.28
PRIMARY Postprandial Triglyceride	41.8; 53.5	0.59
PRIMARY Hepatic Triglyceride	0.05; 0.26	0.35
PRIMARY Matsuda Insulin Sensitivity Index (ISI)	-0.35; -0.40	0.97
PRIMARY Postprandial de Novo Lipogenesis	8.3; 22.3	0.002 sig
PRIMARY M Value During Hyperinsulinemic Euglycemic Clamp	-0.2; 0.2	0.55
SECONDARY Fasting Triglyceride	-3.5; 6.4	0.11
SECONDARY 3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic	23322; -336	0.0032 sig
SECONDARY Hesperetin-3'-O-glucuronide	5550; 4	0.0003 sig
SECONDARY Hesperetin-3',7-0-diglucuronide	3797; -3	0.0012 sig
SECONDARY p-Hydroxyhippuric Acid	20347; -770	0.0023 sig
SECONDARY 3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide	23124; -198	0.0001 sig
SECONDARY Hesperetin-7-O-glucuronide	9556; -2	0.0002 sig
SECONDARY Naringin-7-O-glucuronide	3286; -284	0.0011 sig
SECONDARY Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC)	46.8; 25.6	0.59
SECONDARY Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve	74.7; 0.1	0.046 sig
SECONDARY Fasting de Novo Lipogenesis	0.9; 0.6	0.56

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.

Eligibility 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 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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Data sourced from ClinicalTrials.gov (NCT03527277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.