- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799096
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
January 26, 2016 updated by: Richard Hammersley, University of Hull
This study partially replicates two previous studies with normal weight women, and overweight women.
Both found that women could compensate for sucrose added to the diet in carbonated soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks.
The hypothesis is that this applies also to obese women, who will not gain weight, increase overall energy intake in the diet, or eat differently whilst consuming sucrose.
42 participants shall be randomly assigned to either be given carbonated drinks that contain sucrose, or drinks that are artificially sweetened.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- BMI 30-35 kg/m²
- at least one period of dietary restriction of 4 weeks or more in the last 24 months
Exclusion Criteria:
- dislike of popular sweet carbonated drinks
- dieting during the last month
- history of diabetes
- having an eating disorder
- depression,
- being a smoker
- pregnant
- lactating,
- wearing a pacemaker
- currently taking medication for mood or thyroid disorders
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sucrose
Receives sucrose
|
Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)
Other Names:
|
Placebo Comparator: Aspartame
Receives Aspartame sweetened drinks
|
Intensely sweetened soft drink (no energy content)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight from baseline
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean daily dietary intake estimated from unweighed food diaries
Time Frame: 4 weeks
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rated Mood
Time Frame: 4 weeks
|
Mood was assessed 4 times per day over the study period
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
February 22, 2013
First Submitted That Met QC Criteria
February 22, 2013
First Posted (Estimate)
February 26, 2013
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRRH003
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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