Metabolic SyndromeSSSNCT02143011
Stress and Sugar Synergy
A study testing orange juice and sucrose in people with Metabolic Syndrome and Insulin Resistance, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- What is being tested?
- orange juice and sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center
Sacramento, California, 95655
About this study
Official title: 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.
- Conditions
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- Being tested
- orange juice, sucrose
- Keywords
- sugar, sucrose, fruit juice, orange juice, metabolism, immune cell aging, lipids
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orange juiceOther
intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement
sucroseOther
intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
| Study group | Role | What they receive |
|---|---|---|
| orange juice | Other | no sugar Receives: Other: orange juice; Other: sucrose |
| sugar beverage | Other | no sugar Receives: Other: orange juice; Other: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour triglyceride area under the curve
28 serial blood samples are collected over a 24 hour period.
Measured: Baseline and 2-week intervention
Secondary outcomes (1)
Markers of immune cell aging
Measured: Baseline and 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, USDA, Western Human Nutrition Research Center
- Responsible party
- Sponsor
- Investigators
- Peter Havel, D.V.M, Principal investigator, University of California, DavisKimber Stanhope, Ph.D, R.D., Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143011
- Sponsor's protocol ID
- 574149
- Acronym
- SSS
- Status last verified
- Jan 2019
- First submitted
- 16 May 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Stress and Sugar Feeding on Metabolism
- ClinicalTrials.gov ID
- NCT02143011
- Acronym / sponsor ID
- SSS / 574149
- Conditions
- Metabolic Syndrome, Insulin Resistance, Dyslipidemia
- Keywords
- sugar, sucrose, fruit juice, orange juice, metabolism, immune cell aging, lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco, USDA, Western Human Nutrition Research Center
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orange juice | Other | Other: orange juice, Other: sucroseno sugar |
| sugar beverage | Other | Other: orange juice, Other: sucroseno sugar |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orange juiceintervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement | Other | orange juice, sugar beverage |
| sucroseintervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement | Other | orange juice, sugar beverage |
Primary outcome
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.
1 secondary outcome
Markers of immune cell aging
Time frame: Baseline and 2-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Havel, D.V.M principal investigator
University of California, Davis
Kimber Stanhope, Ph.D, R.D. study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orange juice and sucrose in people with Metabolic Syndrome and Insulin Resistance, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour triglyceride area under the curve (time frame: Baseline and 2-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.