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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sucrose
Aspartame
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sucrose

    Aspartame

    Arm Description

    Receives sucrose

    Receives Aspartame sweetened drinks

    Outcomes

    Primary Outcome Measures

    Change in body weight from baseline

    Secondary Outcome Measures

    Mean daily dietary intake estimated from unweighed food diaries

    Full Information

    First Posted
    February 22, 2013
    Last Updated
    January 26, 2016
    Sponsor
    University of Hull
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01799096
    Brief Title
    Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
    Official Title
    Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Hull

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sucrose
    Arm Type
    Experimental
    Arm Description
    Receives sucrose
    Arm Title
    Aspartame
    Arm Type
    Placebo Comparator
    Arm Description
    Receives Aspartame sweetened drinks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sucrose
    Other Intervention Name(s)
    Irn Bru
    Intervention Description
    Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Aspartame
    Other Intervention Name(s)
    Diet Irn Bru
    Intervention Description
    Intensely sweetened soft drink (no energy content)
    Primary Outcome Measure Information:
    Title
    Change in body weight from baseline
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Mean daily dietary intake estimated from unweighed food diaries
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Rated Mood
    Description
    Mood was assessed 4 times per day over the study period
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24164779
    Citation
    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.
    Results Reference
    derived

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

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