Stress and Sugar Synergy

NCT ID: NCT02143011

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Metabolic Syndrome; Insulin Resistance; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

orange juice

no sugar

Group Type: OTHER

orange juice

Intervention Type: OTHER

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

sucrose

Intervention Type: OTHER

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

sugar beverage

no sugar

Group Type: OTHER

orange juice

Intervention Type: OTHER

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

sucrose

Intervention Type: OTHER

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

Interventions

orange juice

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

Intervention Type: OTHER

sucrose

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Havel, D.V.M

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Kimber Stanhope, Ph.D, R.D.

Role: STUDY_DIRECTOR

University of California, Davis

Locations

Clinical Research Center

Sacramento, California, United States

Countries

United States

Other Identifiers

574149

Identifier Type: -

Identifier Source: org_study_id