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

Primary Purpose

Metabolic Syndrome, Insulin Resistance, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucose
Fructose
High-Fructose Corn Syrup
No sugar (Aspartame)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring sugar, fructose, glucose, HFCS, metabolism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Glucose

Fructose

High-Fructose Corn Syrup

Aspartame

Arm Description

No sugar

Outcomes

Primary Outcome Measures

24-hour triglyceride area under the curve
32 serial blood samples are collected over a 24 hour period.

Secondary Outcome Measures

Insulin sensitivity index
Insulin sensitivity is assessed using the deuterated glucose disposal method.

Full Information

First Posted
April 13, 2010
Last Updated
May 25, 2017
Sponsor
University of California, Davis
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01103921
Brief Title
The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks
Acronym
DRS
Official Title
Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Dyslipidemia
Keywords
sugar, fructose, glucose, HFCS, metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose
Arm Type
Other
Arm Title
Fructose
Arm Type
Other
Arm Title
High-Fructose Corn Syrup
Arm Type
Other
Arm Title
Aspartame
Arm Type
Other
Arm Description
No sugar
Intervention Type
Other
Intervention Name(s)
Glucose
Other Intervention Name(s)
Sugar
Intervention Description
25% dose at 2-week intervention assigned to subjects.
Intervention Type
Other
Intervention Name(s)
Fructose
Other Intervention Name(s)
Sugar
Intervention Description
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Intervention Type
Other
Intervention Name(s)
High-Fructose Corn Syrup
Other Intervention Name(s)
HFCS
Intervention Description
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Intervention Type
Other
Intervention Name(s)
No sugar (Aspartame)
Other Intervention Name(s)
Non-caloric sweetener
Intervention Description
0% dose at 2-week intervention assigned to subjects.
Primary Outcome Measure Information:
Title
24-hour triglyceride area under the curve
Description
32 serial blood samples are collected over a 24 hour period.
Time Frame
Baseline and 2-week intervention
Secondary Outcome Measure Information:
Title
Insulin sensitivity index
Description
Insulin sensitivity is assessed using the deuterated glucose disposal method.
Time Frame
Baseline and 2-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Havel, D.V.M
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimber L Stanhope, Ph.D, R.D.
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34265055
Citation
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.
Results Reference
derived
PubMed Identifier
32916151
Citation
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. Erratum In: Metabolism. 2021 Jun;119:154774.
Results Reference
derived
PubMed Identifier
25904601
Citation
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.
Results Reference
derived
PubMed Identifier
25879513
Citation
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.
Results Reference
derived

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

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