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Stress and Sugar Synergy (SSS)

Primary Purpose

Metabolic Syndrome, Insulin Resistance, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
orange juice
sucrose
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring sugar, sucrose, fruit juice, orange juice, metabolism, immune cell aging, lipids

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

orange juice

sugar beverage

Arm Description

no sugar

no sugar

Outcomes

Primary Outcome Measures

24-hour triglyceride area under the curve
28 serial blood samples are collected over a 24 hour period.

Secondary Outcome Measures

Markers of immune cell aging

Full Information

First Posted
May 16, 2014
Last Updated
January 14, 2019
Sponsor
University of California, Davis
Collaborators
University of California, San Francisco, USDA, Western Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02143011
Brief Title
Stress and Sugar Synergy
Acronym
SSS
Official Title
Synergistic Effects of Stress and Sugar Feeding on Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of California, San Francisco, USDA, Western Human Nutrition Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Dyslipidemia
Keywords
sugar, sucrose, fruit juice, orange juice, metabolism, immune cell aging, lipids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
orange juice
Arm Type
Other
Arm Description
no sugar
Arm Title
sugar beverage
Arm Type
Other
Arm Description
no sugar
Intervention Type
Other
Intervention Name(s)
orange juice
Intervention Description
intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement
Intervention Type
Other
Intervention Name(s)
sucrose
Intervention Description
intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
Primary Outcome Measure Information:
Title
24-hour triglyceride area under the curve
Description
28 serial blood samples are collected over a 24 hour period.
Time Frame
Baseline and 2-week intervention
Secondary Outcome Measure Information:
Title
Markers of immune cell aging
Time Frame
Baseline and 2-week intervention
Other Pre-specified Outcome Measures:
Title
3 hour oral glucose tolerance test
Time Frame
Baseline and 2-week intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Havel, D.V.M
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimber Stanhope, Ph.D, R.D.
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

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Stress and Sugar Synergy

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