Stress and Sugar Synergy

Metabolic Syndrome Clinical Trial

— SSS  

Official title:

Synergistic Effects of Stress and Sugar Feeding on Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143011
• Other study ID #: 574149
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Research Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	University of California, San Francisco, USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3 hour oral glucose tolerance test		Baseline and 2-week intervention
Primary	24-hour triglyceride area under the curve	28 serial blood samples are collected over a 24 hour period.	Baseline and 2-week intervention
Secondary	Markers of immune cell aging		Baseline and 2-week intervention