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Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks (IPOP)

Primary Purpose

Metabolic Syndrome, Insulin Resistance, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucose
Fructose
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

Eligibility Criteria

40 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Glucose

Fructose

Arm Description

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
July 16, 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
NCT01165853
Brief Title
Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks
Acronym
IPOP
Official Title
Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
July 2012 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Dyslipidemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Glucose
Arm Type
Other
Arm Title
Fructose
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Glucose
Other Intervention Name(s)
sugar
Intervention Description
25% dose at 8-week intervention assigned to subjects.
Intervention Type
Other
Intervention Name(s)
Fructose
Other Intervention Name(s)
sugar
Intervention Description
25% dose at 8-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 8-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 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
21956423
Citation
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.
Results Reference
derived
PubMed Identifier
21613559
Citation
Stanhope KL, Griffen SC, Bremer AA, Vink RG, Schaefer EJ, Nakajima K, Schwarz JM, Beysen C, Berglund L, Keim NL, Havel PJ. Metabolic responses to prolonged consumption of glucose- and fructose-sweetened beverages are not associated with postprandial or 24-h glucose and insulin excursions. Am J Clin Nutr. 2011 Jul;94(1):112-9. doi: 10.3945/ajcn.110.002246. Epub 2011 May 25.
Results Reference
derived

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

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