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

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:
  • Irn Bru
Placebo Comparator: Aspartame
Receives Aspartame sweetened drinks
Intensely sweetened soft drink (no energy content)
Other Names:
  • Diet Irn Bru

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.

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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