- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143011
Stress and Sugar Synergy (SSS)
January 14, 2019 updated by: University of California, Davis
Synergistic Effects of Stress and Sugar Feeding on Metabolism
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
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
25 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Body mass index between 28-35
- Self report of stable body weight during the past six months
- High stress participants: Perceived Stress Scores (PSS) ≥ 24, and the presence of a predefined chronically stressful event as assessed by the Telephone screening questions. (IDS scores are not an inclusion criteria in this group, merely a rule-out for the low stress participants).
- 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.
Exclusion Criteria:
- 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
- Diet exclusions: food allergies, special dietary restrictions, habitual ingest of >2 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: orange juice
no sugar
|
intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement
intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
|
|
Other: sugar beverage
no sugar
|
intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement
intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
|
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 2-week intervention
|
28 serial blood samples are collected over a 24 hour period.
|
Baseline and 2-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Markers of immune cell aging
Time Frame: Baseline and 2-week intervention
|
Baseline and 2-week intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
3 hour oral glucose tolerance test
Time Frame: Baseline and 2-week intervention
|
Baseline and 2-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Havel, D.V.M, University of California, Davis
- Study Director: Kimber Stanhope, Ph.D, R.D., University of California, Davis
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 (Actual)
April 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 16, 2014
First Submitted That Met QC Criteria
May 16, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 574149
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.
Clinical Trials on Metabolic Syndrome
-
Sun Yat-sen UniversityNot yet recruitingMetabolic Syndrome Risk Factors | Metabolic Syndrome (MetS)China
-
Meihua JiThe Luhe Teaching Hospital of the Capital Medical UniversityRecruiting
-
Meihua JiThe Luhe Teaching Hospital of the Capital Medical UniversityEnrolling by invitationMetabolic Syndrome (MetS)China
-
National University Health System, SingaporeRecruitingMetabolic Syndrome | Metabolic Syndrome (MetS)Singapore
-
Hacettepe UniversityCompletedMetabolic Syndrome | Metabolic Syndrome Obesity | Metabolic Syndrome ParametersTurkey
-
Universidad de los Andes, ChileCompleted
-
University of KhartoumMinistry of Higher Education and Scientific Research, Republic of SudanCompletedMetabolic Syndrome in Postmenopausal FemalesSudan
-
University of Missouri-ColumbiaRecruitingGlucose Metabolism Disorders | Metabolic Syndrome | Metabolic Syndrome, Protection AgainstUnited States
-
Mayo ClinicCompleted
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
Clinical Trials on orange juice
-
María-Teresa García-ConesaUniversidad Católica San Antonio de MurciaCompleted
-
PepsiCo Global R&DCompletedDigestive HealthUnited States
-
PepsiCo Global R&DCompletedGlycemic ResponseUnited States
-
Loma Linda UniversityCompletedBlood PressureUnited States
-
University of ReadingCompleted
-
Quadram Institute BioscienceBiotechnology and Biological Sciences Research Council; European CommissionCompleted
-
Hasselt UniversityHochschule Geisenheim UniversityCompleted
-
TNOCompletedInflammation | Alcohol ConsumptionNetherlands
-
Rutgers, The State University of New JerseyCompleted
-
University of HohenheimCompleted