NCT01165853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

July 16, 2010

Last Update Submit

May 25, 2017

Conditions

Metabolic SyndromeInsulin ResistanceDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Insulin sensitivity index

    Baseline and 8-week intervention

Study Arms (2)

Glucose

OTHER
Other: Glucose

Fructose

OTHER
Other: Fructose

Interventions

GlucoseOTHER

25% dose at 8-week intervention assigned to subjects.

Also known as: sugar
Glucose
FructoseOTHER

25% dose at 8-week intervention assigned to subjects.

Also known as: sugar
Fructose

Eligibility Criteria

Age40 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

Sacramento, California, 95655, United States

Location

Related Publications (3)

  • 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.

    PMID: 38969065DERIVED

  • 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.

    PMID: 21956423DERIVED

  • 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.

    PMID: 21613559DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceDyslipidemias

Interventions

GlucoseSugarsFructose

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesCarbohydratesKetoses

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 20, 2010

Study Start

July 1, 2005

Primary Completion

November 1, 2007

Study Completion

July 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)