The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks

NCT ID: NCT01103921

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Metabolic Syndrome Insulin Resistance Dyslipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Glucose

Group Type OTHER

Glucose

Intervention Type OTHER

25% dose at 2-week intervention assigned to subjects.

Fructose

Group Type OTHER

Fructose

Intervention Type OTHER

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

High-Fructose Corn Syrup

Group Type OTHER

High-Fructose Corn Syrup

Intervention Type OTHER

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

Aspartame

No sugar

Group Type OTHER

No sugar (Aspartame)

Intervention Type OTHER

0% dose at 2-week intervention assigned to subjects.

Interventions

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Glucose

25% dose at 2-week intervention assigned to subjects.

Intervention Type OTHER

Fructose

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

Intervention Type OTHER

High-Fructose Corn Syrup

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

Intervention Type OTHER

No sugar (Aspartame)

0% dose at 2-week intervention assigned to subjects.

Intervention Type OTHER

Other Intervention Names

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Sugar Sugar HFCS Non-caloric sweetener

Eligibility Criteria

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Inclusion Criteria

* Body mass index between 18-35
* Self report of stable body weight during the past six months

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J Havel, D.V.M

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Kimber L Stanhope, Ph.D, R.D.

Role: STUDY_DIRECTOR

University of California, Davis

Locations

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Clinical Research Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34265055 (View on PubMed)

Hieronimus 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.

Reference Type DERIVED
PMID: 32916151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25904601 (View on PubMed)

Tryon 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.

Reference Type DERIVED
PMID: 25879513 (View on PubMed)

Other Identifiers

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R01HL091333

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL107256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200715772

Identifier Type: -

Identifier Source: org_study_id

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