Metabolic SyndromeDRSNCT01103921
The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks
A study testing Glucose, Fructose and High-Fructose Corn Syrup in people with Metabolic Syndrome and Insulin Resistance, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- What is being tested?
- Glucose, Fructose and High-Fructose Corn Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18-35
- Self report of stable body weight during the past six months
Who cannot join
- Diabetes Mellitus
- Evidence of liver disorder
- Evidence of kidney disorder
- Evidence of thyroid disorder
- Systolic blood pressure consistently over 160mmHg or diastolic blood pressure over 900mmHg
- Triglycerides > 400mg/dl
Show all 15Show fewer
- LDL-C > 240mg/dl
- Hemoglobin < 8.5 g/dl
- Current, prior (within 2 months), or anticipated use of any hypolipidemic or anti-diabetic agents
- Use of Selective Serotonin Reuptake Inhibitors and anti-hypertensive medications
- Any other condition that, in the opinion of the investigators, would put subject at risk
- Strenuous exerciser
- Pregnant or lactating women
- Smoker
- Diet exclusions: food allergies, special dietary restrictions, habitual ingest of >2 alcoholic beverages/day
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center
Sacramento, California, 95655
About this study
Official title: Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance
The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin.
Read the detailed description
The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or HFCS-sweetened beverages (providing 10%, 17.5% or 25% of energy) with meals. In addition, there will be two control groups, with one group consuming 0% sugar beverages sweetened with sucralose and the other consuming glucose-sweetened beverages at 25% of energy requirement. Experimental procedures, including 24-hour serial blood sampling, post-heparin infusions, gluteal biopsies, Magnetic Resonance Imaging of the liver and the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 2-week intervention period at the UC Davis Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC). During the inpatient periods, subjects are served energy balanced diets. The diets provide 15% of energy as protein, 30% as fat, and 55% as carbohydrate. During baseline testing, the carbohydrate content consists primarily of complex carbohydrate (>97%). During intervention the 55% carbohydrate will consist of 10% sugar/45% complex, 17.5% sugar/37.5% complex, or 25% sugar/30% complex depending on the diet group to which the subject is assigned. During the outpatient intervention periods, the subjects reside at home and are provided with fructose- or HFCS -sweetened beverages that are consumed with each meal along with a self-selected ad libitum (usual) diet.
- Conditions
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- Being tested
- Glucose, Fructose, High-Fructose Corn Syrup, No sugar (Aspartame)
- Keywords
- sugar, fructose, glucose, HFCS, metabolism
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseOther
Also called Sugar
25% dose at 2-week intervention assigned to subjects.
FructoseOther
Also called Sugar
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
High-Fructose Corn SyrupOther
Also called HFCS
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
No sugar (Aspartame)Other
Also called Non-caloric sweetener
0% dose at 2-week intervention assigned to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Other | Not described Receives: Other: Glucose |
| Fructose | Other | Not described Receives: Other: Fructose |
| High-Fructose Corn Syrup | Other | Not described Receives: Other: High-Fructose Corn Syrup |
| Aspartame | Other | No sugar Receives: Other: No sugar (Aspartame) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour triglyceride area under the curve
32 serial blood samples are collected over a 24 hour period.
Measured: Baseline and 2-week intervention
Secondary outcomes (1)
Insulin sensitivity index
Insulin sensitivity is assessed using the deuterated glucose disposal method.
Measured: Baseline and 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Peter J Havel, D.V.M, Principal investigator, University of California, DavisKimber L Stanhope, Ph.D, R.D., Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103921
- Sponsor's protocol ID
- 200715772
- Other IDs
- R01HL091333, R01HL107256
- Acronym
- DRS
- Status last verified
- May 2017
- First submitted
- 13 Apr 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sigala DM, Hieronimus B, Medici V, Lee V, Nunez MV, Bremer AA, Cox CL, Price CA, Benyam Y, Chaudhari AJ, Abdelhafez Y, McGahan JP, Goran MI, Sirlin CB, Pacini G, Tura A, Keim NL, Havel PJ, Stanhope KL. Consuming Sucrose- or HFCS-sweetened Beverages Increases Hepatic Lipid and Decreases Insulin Sensitivity in Adults. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3248-3264. doi: 10.1210/clinem/dgab508.
PubMed 34265055Hieronimus B, Medici V, Bremer AA, Lee V, Nunez MV, Sigala DM, Keim NL, Havel PJ, Stanhope KL. Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults. Metabolism. 2020 Nov;112:154356. doi: 10.1016/j.metabol.2020.154356. Epub 2020 Sep 9.
PubMed 32916151Stanhope 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 25904601Tryon MS, Stanhope KL, Epel ES, Mason AE, Brown R, Medici V, Havel PJ, Laugero KD. Excessive Sugar Consumption May Be a Difficult Habit to Break: A View From the Brain and Body. J Clin Endocrinol Metab. 2015 Jun;100(6):2239-47. doi: 10.1210/jc.2014-4353. Epub 2015 Apr 16.
PubMed 25879513
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance
- ClinicalTrials.gov ID
- NCT01103921
- Acronym / sponsor ID
- DRS / 200715772
- Conditions
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- Keywords
- sugar, fructose, glucose, HFCS, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin.
Detailed description
The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or HFCS-sweetened beverages (providing 10%, 17.5% or 25% of energy) with meals. In addition, there will be two control groups, with one group consuming 0% sugar beverages sweetened with sucralose and the other consuming glucose-sweetened beverages at 25% of energy requirement. Experimental procedures, including 24-hour serial blood sampling, post-heparin infusions, gluteal biopsies, Magnetic Resonance Imaging of the liver and the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 2-week intervention period at the UC Davis Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC). During the inpatient periods, subjects are served energy balanced diets. The diets provide 15% of energy as protein, 30% as fat, and 55% as carbohydrate. During baseline testing, the carbohydrate content consists primarily of complex carbohydrate (>97%). During intervention the 55% carbohydrate will consist of 10% sugar/45% complex, 17.5% sugar/37.5% complex, or 25% sugar/30% complex depending on the diet group to which the subject is assigned. During the outpatient intervention periods, the subjects reside at home and are provided with fructose- or HFCS -sweetened beverages that are consumed with each meal along with a self-selected ad libitum (usual) diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose | Other | Other: Glucose |
| Fructose | Other | Other: Fructose |
| High-Fructose Corn Syrup | Other | Other: High-Fructose Corn Syrup |
| Aspartame | Other | Other: No sugar (Aspartame)No sugar |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18-35
- Self report of stable body weight during the past six months
Key exclusion criteria (15 listed)
- Diabetes Mellitus
- Evidence of liver disorder
- Evidence of kidney disorder
- Evidence of thyroid disorder
- Systolic blood pressure consistently over 160mmHg or diastolic blood pressure over 900mmHg
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 |
|---|---|---|
| GlucoseAlso: Sugar25% dose at 2-week intervention assigned to subjects. | Other | Glucose |
| FructoseAlso: Sugar25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects. | Other | Fructose |
| High-Fructose Corn SyrupAlso: HFCS25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects. | Other | High-Fructose Corn Syrup |
| No sugar (Aspartame)Also: Non-caloric sweetener0% dose at 2-week intervention assigned to subjects. | Other | Aspartame |
Primary outcome
24-hour triglyceride area under the curve
Time frame: Baseline and 2-week intervention
32 serial blood samples are collected over a 24 hour period.
1 secondary outcome
Insulin sensitivity index
Time frame: Baseline and 2-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 34265055Sigala DM, Hieronimus B, Medici V, Lee V, Nunez MV, Bremer AA, Cox CL, Price CA, Benyam Y, Chaudhari AJ, Abdelhafez Y, McGahan JP, Goran MI, Sirlin CB, Pacini G, Tura A, Keim NL, Havel PJ, Stanhope KL. Consuming Sucrose- or HFCS-sweetened Beverages Increases Hepatic Lipid and Decreases Insulin Sensitivity in Adults. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3248-3264. doi: 10.1210/clinem/dgab508.
- Derived from this study: PubMed 32916151Hieronimus B, Medici V, Bremer AA, Lee V, Nunez MV, Sigala DM, Keim NL, Havel PJ, Stanhope KL. Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults. Metabolism. 2020 Nov;112:154356. doi: 10.1016/j.metabol.2020.154356. Epub 2020 Sep 9.
- Derived from this study: 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.
- Derived from this study: PubMed 25879513Tryon MS, Stanhope KL, Epel ES, Mason AE, Brown R, Medici V, Havel PJ, Laugero KD. Excessive Sugar Consumption May Be a Difficult Habit to Break: A View From the Brain and Body. J Clin Endocrinol Metab. 2015 Jun;100(6):2239-47. doi: 10.1210/jc.2014-4353. Epub 2015 Apr 16.
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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.
Peter J Havel, D.V.M principal investigator
University of California, Davis
Kimber L Stanhope, Ph.D, R.D. study director
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 Glucose, Fructose and High-Fructose Corn Syrup in people with Metabolic Syndrome and Insulin Resistance, 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 2 inclusion and 15 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 30 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
24-hour triglyceride area under the curve (time frame: Baseline and 2-week intervention). 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 NCT01103921, which also lists 4 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 30 May 2017.