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

May 25, 2017 updated by: University of California, Davis

Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95655
        • Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Glucose
Other: Glucose
25% dose at 8-week intervention assigned to subjects.
Other Names:
  • sugar
Other: Fructose
Other: Fructose
25% dose at 8-week intervention assigned to subjects.
Other Names:
  • sugar

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Peter J Havel, D.V.M., University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200412368
  • R01HL075675 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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