ObesityNCT01799096
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
A study testing Sucrose and Aspartame in people with Obesity, run by University of Hull.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sucrose and Aspartame
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- BMI 30-35 kg/m²
- at least one period of dietary restriction of 4 weeks or more in the last 24 months
Who cannot join
- dislike of popular sweet carbonated drinks
- dieting during the last month
- history of diabetes
- having an eating disorder
- depression,
- being a smoker
Show all 10Show fewer
- pregnant
- lactating,
- wearing a pacemaker
- currently taking medication for mood or thyroid disorders
About this study
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.
- Conditions
- Obesity
- Being tested
- Sucrose, Aspartame
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDietary supplement
Also called Irn Bru
Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)
AspartameDietary supplement
Also called Diet Irn Bru
Intensely sweetened soft drink (no energy content)
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Receives sucrose Receives: Dietary Supplement: Sucrose |
| Aspartame | Placebo comparator | Receives Aspartame sweetened drinks Receives: Dietary Supplement: Aspartame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline
Measured: 4 weeks
Secondary outcomes (1)
Mean daily dietary intake estimated from unweighed food diaries
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startSep 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Hammersley, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799096
- Sponsor's protocol ID
- MRRH003
- Status last verified
- Jan 2016
- First submitted
- 22 Feb 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24164779
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
- ClinicalTrials.gov ID
- NCT01799096
- Acronym / sponsor ID
- MRRH003
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Dietary Supplement: SucroseReceives sucrose |
| Aspartame | Placebo comparator | Dietary Supplement: AspartameReceives Aspartame sweetened drinks |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- BMI 30-35 kg/m²
- at least one period of dietary restriction of 4 weeks or more in the last 24 months
Key exclusion criteria (10 listed)
- dislike of popular sweet carbonated drinks
- dieting during the last month
- history of diabetes
- having an eating disorder
- depression,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucroseAlso: Irn BruSucrose in carbonated soft drinks (4 x250ml total1800 kJ per day) | Dietary supplement | Sucrose |
| AspartameAlso: Diet Irn BruIntensely sweetened soft drink (no energy content) | Dietary supplement | Aspartame |
Primary outcome
Change in body weight from baseline
Time frame: 4 weeks
1 secondary outcome
Mean daily dietary intake estimated from unweighed food diaries
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 24164779Reid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose and Aspartame in people with Obesity, run by University of Hull.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.