Clinical trial NCT02143011: Stress and Sugar Synergy
Official title: Synergistic Effects of Stress and Sugar Feeding on Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Dyslipidemia
Keywords: sugar
sucrose
fruit juice
orange juice
metabolism
immune cell aging
lipids
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: USDA, Western Human Nutrition Research Center
First posted: 2014-05-20
Enrollment: 23
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 24-hour triglyceride area under the curve
timeFrame: Baseline and 2-week intervention
Secondary outcomes:
measure: Markers of immune cell aging
timeFrame: Baseline and 2-week intervention
Other outcomes:
measure: 3 hour oral glucose tolerance test
timeFrame: Baseline and 2-week intervention
Locations:
city: Sacramento
country: United States
facility: Clinical Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter Havel, D.V.M
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Kimber Stanhope, Ph.D, R.D.
role: STUDY_DIRECTOR
References: