Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799096
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Richard Hammersley, University of Hull

Tracking Information
First Submitted Date  ICMJE February 22, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
Change in body weight from baseline [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
Mean daily dietary intake estimated from unweighed food diaries [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 22, 2013)
Rated Mood [ Time Frame: 4 weeks ]
Mood was assessed 4 times per day over the study period
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
Official Title  ICMJE Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Sucrose
    Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)
    Other Name: Irn Bru
  • Dietary Supplement: Aspartame
    Intensely sweetened soft drink (no energy content)
    Other Name: Diet Irn Bru
Study Arms  ICMJE
  • Experimental: Sucrose
    Receives sucrose
    Intervention: Dietary Supplement: Sucrose
  • Placebo Comparator: Aspartame
    Receives Aspartame sweetened drinks
    Intervention: Dietary Supplement: Aspartame
Publications * Reid M, Hammersley R, Duffy M, Ballantyne C. Effects on obese women of the sugar sucrose added to the diet over 28 d: a quasi-randomised, single-blind, controlled trial. Br J Nutr. 2014 Feb;111(3):563-70. doi: 10.1017/S0007114513002687. Epub 2013 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2013)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799096
Other Study ID Numbers  ICMJE MRRH003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Hammersley, University of Hull
Study Sponsor  ICMJE University of Hull
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Hull
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP