Cardiovascular Risk FactorOASISNCT03527277
Orange Juice And Sugar Intervention Study
A study testing Naturally-sweetened orange juice and Sugar-sweetened beverage in people with Cardiovascular Risk Factor and Type2 Diabetes Mellitus, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Type2 Diabetes Mellitus, Insulin Sensitivity
- What is being tested?
- Naturally-sweetened orange juice and Sugar-sweetened beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 28 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
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
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- Conditions
- Cardiovascular Risk Factor, Type2 Diabetes Mellitus, Insulin Sensitivity, Metabolic Syndrome
- Being tested
- Naturally-sweetened orange juice, Sugar-sweetened beverage
- 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
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturally-sweetened orange juiceOther
Commercially-available ready-to-serve refrigerated orange juice
Sugar-sweetened beverageOther
Sugar-sweetened water flavored with Kool-Aid (TM)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sugar-sweetened beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Low Density Lipoprotein Cholesterol (LDL-C)
Absolute change of plasma LDL-C concentration (4 week value - 0 week value)
Measured: 4 weeks
Postprandial Low Density Lipoprotein Cholesterol (LDL-C)
Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value)
Measured: 4 weeks
Fasting Apolipoprotein B (apoB)
Absolute change of plasma apoB concentration (4 week value - 0 week value)
Measured: 4 weeks
Postprandial Apolipoprotein B (apoB)
Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value)
Measured: 4 weeks
Fasting Uric Acid
Absolute change of plasma uric acid concentration (4 week value - 0 week value)
Measured: 4 weeks
Postprandial Uric Acid
Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value)
Measured: 4 weeks
Fasting Apolipoprotein CIII (apoCIII)
Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value)
Measured: 4 weeks
Postprandial Apolipoprotein CIII (apoCIII)
Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)
Measured: 4 weeks
Postprandial Triglyceride
Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value)
Measured: 4 weeks
Hepatic Triglyceride
Absolute change of % hepatic triglyceride (4 week value - 0 week value)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 4 weeks
Secondary outcomes (11)
Fasting Triglyceride
Absolute change of plasma fasting triglyceride concentration (4 week value - 0 week value)
Measured: 4 weeks
3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic
Absolute change of total 24-hour urinary 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic (4 week value - 0 week value)
Measured: 4 weeks
Hesperetin-3'-O-glucuronide
Absolute change of total 24-hour urinary hesperetin-3'-O-glucuronide (4 week value - 0 week value)Urine concentration hesperetin-3'-O-glucuronide
Measured: 4 weeks
Hesperetin-3',7-0-diglucuronide
Absolute change of total 24-hour urinary hesperetin-3',7-0-diglucuronide (4 week value - 0 week value)
Measured: 4 weeks
p-Hydroxyhippuric Acid
Absolute change of total 24-hour urinary p-Hydroxyhippuric acid (4 week value - 0 week value)
Measured: 4 weeks
3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide
Absolute change of total 24-hour urinary 3-(4'-methoxyphenyl)propionic acid-3'-O-glucuronide (4 week value - 0 week value)
Measured: 4 weeks
Hesperetin-7-O-glucuronide
Absolute change of total 24-hour urinary hesperetin-7-O-glucuronide (4 week value - 0 week value)
Measured: 4 weeks
Naringin-7-O-glucuronide
Absolute change of total 24-hour urinary naringen-7-O-glucuronide (4 week value - 0 week value)
Measured: 4 weeks
Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC)
Absolute change in OGTT 3-hour AUC glucose concentration (4-week value - 0-week value)
Measured: 4 week
Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve
Absolute change in OGTT 3-hour AUC insulin concentration (4-week value - 0-week value)
Measured: 4 week
Fasting de Novo Lipogenesis
Absolute change of fasting percentage fractional rate fasting de novo lipogenesis DNL (4 week value - 0 week value)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jun 2018
- Primary completion28 May 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Touro University, California, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kimber Stanhope, University of California, Davis
- Investigators
- Kimber L Stanhope, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527277
- Sponsor's protocol ID
- 1167030
- Other IDs
- R01HL137716
- Acronym
- OASIS
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2018
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final dataset will include data collected specifically for the study and data provided during screening in the medical history form. This includes some demographic information and data regarding family history of disease. We will make data and demographic information available to other investigators upon request. The dataset will be stripped of all unique identifiers and subject characteristics and prepared in accordance with all HIPAA regulations prior to release for sharing. Study outcome results will be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.
Publications
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.
PubMed 24493081Stanhope 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.
PubMed 25904601
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03527277
- Acronym / sponsor ID
- OASIS / 1167030
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Touro University, California, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Naturally-sweetened orange juice | Experimental | Other: Naturally-sweetened orange juiceNaturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks |
| Sugar-sweetened beverage | Active comparator | Other: Sugar-sweetened beverageSugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturally-sweetened orange juiceCommercially-available ready-to-serve refrigerated orange juice | Other | Naturally-sweetened orange juice |
| Sugar-sweetened beverageSugar-sweetened water flavored with Kool-Aid (TM) | Other | Sugar-sweetened beverage |
Primary outcome
Fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 4 weeks
Absolute change of plasma LDL-C concentration (4 week value - 0 week value)
Postprandial Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 4 weeks
Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value)
Fasting Apolipoprotein B (apoB)
Time frame: 4 weeks
Absolute change of plasma apoB concentration (4 week value - 0 week value)
Postprandial Apolipoprotein B (apoB)
Time frame: 4 weeks
Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value)
Fasting Uric Acid
Time frame: 4 weeks
Absolute change of plasma uric acid concentration (4 week value - 0 week value)
Postprandial Uric Acid
Time frame: 4 weeks
Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value)
Fasting Apolipoprotein CIII (apoCIII)
Time frame: 4 weeks
Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value)
Postprandial Apolipoprotein CIII (apoCIII)
Time frame: 4 weeks
Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)
Postprandial Triglyceride
Time frame: 4 weeks
Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value)
Hepatic Triglyceride
Time frame: 4 weeks
Absolute change of % hepatic triglyceride (4 week value - 0 week value)
Matsuda Insulin Sensitivity Index (ISI)
Time frame: 4 week
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).
Postprandial de Novo Lipogenesis
Time frame: 4 weeks
Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value)
M Value During Hyperinsulinemic Euglycemic Clamp
Time frame: 4 weeks
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)
11 secondary outcomes
Fasting Triglyceride
Time frame: 4 weeks
3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic
Time frame: 4 weeks
Hesperetin-3'-O-glucuronide
Time frame: 4 weeks
Hesperetin-3',7-0-diglucuronide
Time frame: 4 weeks
p-Hydroxyhippuric Acid
Time frame: 4 weeks
3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide
Time frame: 4 weeks
Hesperetin-7-O-glucuronide
Time frame: 4 weeks
Naringin-7-O-glucuronide
Time frame: 4 weeks
Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC)
Time frame: 4 week
Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve
Time frame: 4 week
Fasting de Novo Lipogenesis
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24493081Yang 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.
- Results publication: PubMed 25904601Stanhope 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.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Final dataset will include data collected specifically for the study and data provided during screening in the medical history form. This includes some demographic information and data regarding family history of disease. We will make data and demographic information available to other investigators upon request. The dataset will be stripped of all unique identifiers and subject characteristics and prepared in accordance with all HIPAA regulations prior to release for sharing. Study outcome results will be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimber L Stanhope, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naturally-sweetened orange juice and Sugar-sweetened beverage in people with Cardiovascular Risk Factor and Type2 Diabetes Mellitus, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Low Density Lipoprotein Cholesterol (LDL-C) (time frame: 4 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.