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

March 15, 2021 updated by: Richard Hammersley, University of Hull

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 25-35

Exclusion Criteria:

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sucrose
Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks
Dietary supplement: Sucrose
Sucrose sweetened soft drinks
Other Names:
  • Aspartame
  • Aspartame sweetened soft drinks as comparator
Placebo Comparator: Aspartame
Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks
Dietary supplement: Sucrose
Sucrose sweetened soft drinks
Other Names:
  • Aspartame
  • Aspartame sweetened soft drinks as comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass
Time Frame: Eight Weeks
Do participants gain weight?
Eight Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hull

Investigators

  • Study Chair: Richard Hammersley, PhD, University of Hull

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

August 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY4272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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