NCT01799096

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

February 22, 2013

Last Update Submit

January 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight from baseline

    4 weeks

Secondary Outcomes (1)

  • Mean daily dietary intake estimated from unweighed food diaries

    4 weeks

Other Outcomes (1)

  • Rated Mood

    4 weeks

Study Arms (2)

Sucrose

EXPERIMENTAL

Receives sucrose

Dietary Supplement: Sucrose

Aspartame

PLACEBO COMPARATOR

Receives Aspartame sweetened drinks

Dietary Supplement: Aspartame

Interventions

SucroseDIETARY_SUPPLEMENT

Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)

Also known as: Irn Bru
Sucrose
AspartameDIETARY_SUPPLEMENT

Intensely sweetened soft drink (no energy content)

Also known as: Diet Irn Bru
Aspartame

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • BMI 30-35 kg/m²
  • at least one period of dietary restriction of 4 weeks or more in the last 24 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

SucroseAspartame

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 26, 2013

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 28, 2016

Record last verified: 2016-01