- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090478
The Effect of Dietary Sugar Consumption on Sweet Taste Perception
March 14, 2014 updated by: Paul Wise, Monell Chemical Senses Center
The purpose of the study is to determine how reducing the amount of simple sugars in the diet affects sweet taste perception. Healthy adult subjects will be assigned to either follow their usual diet, or to replace sugar calories with fats or starch.
The investigators hypothesize that eating less sugar will:
- cause foods and drinks with a given amount of sugar to taste sweeter
- cause people to prefer lower levels of sugar in foods and drinks
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19014
- Monell Chemical Senses Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Good general heath (by self report)
- Consume at least 2 sugar-containing soft drinks/day on average)
- Able to control diet (select their own foods)
Exclusion Criteria:
- Major illness of any kind within the last six months, or any chronic illness
- Daily use of medication, except for birth control, vitamins, and aspirin
- Regularly consume non-nutritive sweeteners
- Pregnant women
- Gained or lost 10% or more of their body weight in the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: No change in dietary sugar levels
Group met with a dietician as often as the control group to discuss diet, but the dietician gave them advice geared toward no change in dietary sugar levels
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Subjects in the control group will meet with a dietician and discuss diet records, but the dietician will not instruct the control subjects to reduce the number of calories from simple sugars in the diet
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Experimental: Low sugar group
Subjects met with a dietician who discussed diet records.
After the first month (baseline, regular diet), the dietician made suggestions geared toward reducing calories from simple sugars by 40%.
This will be achieved by replacing sugar calories with complex carbohydrates and fats, while maintaining energy balance (same number of calories as the baseline month).
|
All subjects followed their usual diet during month 1.
For months 2-4: sham diet intervention for the control group, 40% reduction in sugar calories for the experimental group.
All subjects were allowed to chose any diet they wished during month 5.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sweet Taste Intensity over Five Months
Time Frame: Monthly (for five months)
|
Subjects rated the sweetness of pudding and beverage samples that varied in sucrose concentration during each study month to determine how perception changes over time with diet manipulations
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Monthly (for five months)
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Change in Pleasantness Over Five Months
Time Frame: Monthly (five month participation duration total)
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Subjects rated hedonic value (degree to which the sample was pleasant) for model pudding and beverages that differed in concentration of sucrose once each month over five months to determine how perception changed over time with the diet manipulation
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Monthly (five month participation duration total)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sucrose detection thresholds
Time Frame: Every month (for five months)
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Test of the minimum concentration of sucrose solution that subjects can discriminate from water.
Forced-choice, ascending concentration method.
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Every month (for five months)
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Body mass index
Time Frame: Every month (five months total)
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BMI, calculated based on weight and height.
This was measured both to balance treatment groups and to ensure that assigned diets maintained adequate energy balance (no change in BMI over the study was the ideal outcome for all groups)
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Every month (five months total)
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Diet records
Time Frame: Every month (five month total)
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Subject reported in detail the types and quantities of the foods and beverages they ate.
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Every month (five month total)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
March 13, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 18, 2014
Study Record Updates
Last Update Posted (Estimate)
March 18, 2014
Last Update Submitted That Met QC Criteria
March 14, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- IND039A01WISE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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