Effects of the Sugar Sucrose on Bodyweight and Energy Int... | NCT01799096

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

NCT01799096

Sponsor

University of Hull

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

41Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Sucrose
Aspartame

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Feb 22, 2013

First Submission Date that Met QC Criteria

Feb 22, 2013

First Posted Date

Feb 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose	Experimental	Receives sucrose	Dietary Supplement: Sucrose
Aspartame	Placebo Comparator	Receives Aspartame sweetened drinks	Dietary Supplement: Aspartame

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sucrose	Dietary Supplement	Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)	Sucrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body weight from baseline		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean daily dietary intake estimated from unweighed food diaries		4 weeks

Other Outcomes

Measure	Description	Time Frame
Rated Mood	Mood was assessed 4 times per day over the study period	4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24164779	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates