OverweightNCT04804397
Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
A study testing Sucrose in people with Overweight, run by University of Hull.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jun 2013
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-35
Who cannot join
- Diabetes,
- other health problems,
- medication,
- dislike of soft drinks
About this study
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.
- Conditions
- Overweight
- Being tested
- Sucrose
- Keywords
- Sucrose, Sugar, Carbohydrate, Weight gain, men
- Medical subject headings
- Overweight, Weight Gain, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDietary supplement
Also called Aspartame, Aspartame sweetened soft drinks as comparator
Sucrose sweetened soft drinks
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks Receives: Dietary Supplement: Sucrose |
| Aspartame | Placebo comparator | Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks Receives: Dietary Supplement: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass
Do participants gain weight?
Measured: Eight Weeks
Secondary outcomes (2)
Daily energy intake assessed by free-living unweighed food diary
Do participants eat less to compensate for added sucrose?
Measured: Eight Weeks
Mood assessed using 10 rating scales
Are there changes in rated mood during sucrose supplementation?
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study startAug 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- Investigators
- Richard Hammersley, PhD, Study chair, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804397
- Sponsor's protocol ID
- PSY4272
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
- ClinicalTrials.gov ID
- NCT04804397
- Acronym / sponsor ID
- PSY4272
- Conditions
- Overweight
- Keywords
- Sucrose, Sugar, Carbohydrate, Weight gain, men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Mar 2021 (actual)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Dietary Supplement: SucroseSucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks |
| Aspartame | Placebo comparator | Dietary Supplement: SucroseAspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 25-35
Key exclusion criteria (4 listed)
- Diabetes,
- other health problems,
- medication,
- dislike of soft drinks
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: Aspartame, Aspartame sweetened soft drinks as comparatorSucrose sweetened soft drinks | Dietary supplement | Aspartame, Sucrose |
Primary outcome
Body Mass
Time frame: Eight Weeks
Do participants gain weight?
2 secondary outcomes
Daily energy intake assessed by free-living unweighed food diary
Time frame: Eight Weeks
Mood assessed using 10 rating scales
Time frame: Eight 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 18 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Richard Hammersley, PhD study chair
University of Hull
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose in people with Overweight, 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 1 inclusion and 4 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 18 Mar 2021. 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?
Body Mass (time frame: Eight Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.