NCT02143011

Brief Summary

The main objectives of this study are to test the hypotheses that: 1) consumption of beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic psychological stress may augment the adverse metabolic effects of sugar intake. The study intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a sucrose-sweetened beverage or naturally-sweetened orange juice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration 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

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

May 16, 2014

Last Update Submit

January 14, 2019

Conditions

Metabolic SyndromeInsulin ResistanceDyslipidemia

Keywords

sugarsucrosefruit juiceorange juicemetabolismimmune cell aginglipids

Outcome Measures

Primary Outcomes (1)

  • 24-hour triglyceride area under the curve

    28 serial blood samples are collected over a 24 hour period.

    Baseline and 2-week intervention

Secondary Outcomes (1)

  • Markers of immune cell aging

    Baseline and 2-week intervention

Other Outcomes (1)

  • 3 hour oral glucose tolerance test

    Baseline and 2-week intervention

Study Arms (2)

orange juice

OTHER

no sugar

Other: orange juiceOther: sucrose

sugar beverage

OTHER

no sugar

Other: orange juiceOther: sucrose

Interventions

orange juiceOTHER

intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement

orange juicesugar beverage
sucroseOTHER

intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement

orange juicesugar beverage

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index between 28-35
  • Self report of stable body weight during the past six months
  • Low stress participants: PSS scores ≤ 8, Inventory for Depressive Symptom (IDS) scores ≤ 14, and the absence of any predefined chronically stressful events as assessed by the telephone screening questions.

You may not qualify if:

  • glucose intolerance
  • Evidence of liver disorder
  • Evidence of kidney disorder
  • Evidence of thyroid disorder
  • Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
  • Triglycerides \> 200mg/dl
  • LDL-C \> 130mg/dl
  • Hemoglobin \< 8.5 g/dl
  • pregnant or lactating women
  • Current, prior (within 12 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
  • surgery for weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

Sacramento, California, 95655, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceDyslipidemias

Interventions

Sucrose

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Peter Havel, D.V.M

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Kimber Stanhope, Ph.D, R.D.

    University of California, Davis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 20, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)