Effects of Consuming Sugar-Sweetened Beverages With Meals... | NCT01165853

Studies
Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks

NCT01165853

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome
Insulin Resistance
Dyslipidemia

Interventions

Glucose
Fructose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL075675	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Nov 2007Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 16, 2010

First Submission Date that Met QC Criteria

Jul 16, 2010

First Posted Date

Jul 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy the body burns as well as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's sensitivity to the insulin.

Detailed Description

The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or glucose-sweetened beverages (25% of energy) with meals. Experimental procedures, including 24-hour serial blood sampling, 26-h stable isotoped infusions, post-heparin blood collection, gluteal biopsies, metabolic rate monitoring, computed tomography scans of the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 10-week intervention period at the UC Davis School of Medicine/Sacramento Veterans Affairs Medical Center Clinical Research Center (CCRC). During the 2-week inpatient baseline period, subjects are served energy balanced diets containing 15% of energy as protein, 30% as fat, and 55% as complex carbohydrate. Following the baseline period, the subjects reside at home for 8 weeks and consume their usual ad libitum diet along with 25% of energy requirements as fructose- or glucose-sweetened beverages. Subjects then return to the CCRC for the 2-week inpatient intervention period at the end of the study and are served energy-balanced diets containing 15% of energy as protein, 30% as fat, 30% as complex carbohydrate and 25% of energy as fructose- or glucose-sweetened beverage.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose	Other		Other: Glucose
Fructose	Other		Other: Fructose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose	Other	25% dose at 8-week intervention assigned to subjects.	Glucose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour triglyceride area under the curve	32 serial blood samples are collected over a 24 hour period.	Baseline and 8-week intervention

Secondary Outcomes

Measure	Description	Time Frame
Insulin sensitivity index	Insulin sensitivity is assessed using the deuterated glucose disposal method.	Baseline and 8-week intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self-report of stable body weight
Women were post-menopausal based on a self-report of no menstruation for at least one year

Exclusion Criteria:

evidence of diabetes
renal or hepatic disease
fasting serum TG concentrations >400 mg/dl
hypertension (>140/90 mg Hg)
surgery for weight loss
individuals who smoked
reported exercise of more than 3.5 hours/week at a level more vigorous than walking
having used thyroid, lipid-lowering, glucose-lowering, anti-hypertensive, anti-depressant, or weight loss medications
habitual ingestion of more than one sugar-sweetened beverage/day or more than two alcoholic beverages/day

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter J Havel, D.V.M.	University of California, Davis	Principal Investigator
Kimber L Stanhope, Ph.D, R.D.	University of California, Davis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center		Sacramento	California	95655	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38969065	Derived	Law HG, Stanhope KL, Zhang W, Myagmarsuren M, Jamshed ZM, Khan MA, Bang H, Havel PJ, Berglund L, Enkhmaa B. Lipoprotein(a) and diet: consuming sugar-sweetened beverages lowers lipoprotein(a) levels in obese and overweight adults. J Lipid Res. 2024 Aug;65(8):100588. doi: 10.1016/j.jlr.2024.100588. Epub 2024 Jul 4.
21956423	Derived	Cox CL, Stanhope KL, Schwarz JM, Graham JL, Hatcher B, Griffen SC, Bremer AA, Berglund L, McGahan JP, Keim NL, Havel PJ. Circulating concentrations of monocyte chemoattractant protein-1, plasminogen activator inhibitor-1, and soluble leukocyte adhesion molecule-1 in overweight/obese men and women consuming fructose- or glucose-sweetened beverages for 10 weeks. J Clin Endocrinol Metab. 2011 Dec;96(12):E2034-8. doi: 10.1210/jc.2011-1050. Epub 2011 Sep 28.

ID	Term
D024821	Metabolic Syndrome
D007333	Insulin Resistance
D050171	Dyslipidemias

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D005947	Glucose
D000073893	Sugars
D005632	Fructose

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D002241	Carbohydrates
D007661	Ketoses