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Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men

Primary Purpose

Overweight

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

About this trial

This is an interventional basic science trial for Overweight focused on measuring Sucrose, Sugar, Carbohydrate, Weight gain, men

Eligibility Criteria

30 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 25-35

Exclusion Criteria:

  • Diabetes,
  • other health problems,
  • medication,
  • dislike of soft drinks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sucrose

    Aspartame

    Arm Description

    Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks

    Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks

    Outcomes

    Primary Outcome Measures

    Body Mass
    Do participants gain weight?

    Secondary Outcome Measures

    Daily energy intake assessed by free-living unweighed food diary
    Do participants eat less to compensate for added sucrose?
    Mood assessed using 10 rating scales
    Are there changes in rated mood during sucrose supplementation?

    Full Information

    First Posted
    January 26, 2016
    Last Updated
    March 15, 2021
    Sponsor
    University of Hull
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04804397
    Brief Title
    Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
    Official Title
    Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (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
    Background: Sugar intake, especially in liquid, correlates with obesity. Yet, whether it is a special cause of obesity is less clear. Few experimental studies exist. Aim: To replicate the investigators' previous 4 week experiments on women with men over 8 weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy intake is affected. Participants: 80 men BMI 25-35, aged 30-55. Procedure: After a week of baseline, over eight weeks single blind 40 men received soft drinks containing sucrose (1650 KJ, 97g carbohydrate per day), 40 received control drinks. A three-day food diary with mood ratings and activity levels was completed during baseline and weeks 1, 4 and 8 of the experiment. Body mass was recorded weekly with other anthropometric measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    Sucrose, Sugar, Carbohydrate, Weight gain, men

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sucrose
    Arm Type
    Experimental
    Arm Description
    Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks
    Arm Title
    Aspartame
    Arm Type
    Placebo Comparator
    Arm Description
    Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sucrose
    Other Intervention Name(s)
    Aspartame, Aspartame sweetened soft drinks as comparator
    Intervention Description
    Sucrose sweetened soft drinks
    Primary Outcome Measure Information:
    Title
    Body Mass
    Description
    Do participants gain weight?
    Time Frame
    Eight Weeks
    Secondary Outcome Measure Information:
    Title
    Daily energy intake assessed by free-living unweighed food diary
    Description
    Do participants eat less to compensate for added sucrose?
    Time Frame
    Eight Weeks
    Title
    Mood assessed using 10 rating scales
    Description
    Are there changes in rated mood during sucrose supplementation?
    Time Frame
    Eight Weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI 25-35 Exclusion Criteria: Diabetes, other health problems, medication, dislike of soft drinks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Hammersley, PhD
    Organizational Affiliation
    University of Hull
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men

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