Overweight and ObesityNCT03652207
Effects of Palatinose™ on Weight Management and Body Composition
A study testing isomaltulose (Palatinose(TM) and Sucrose in people with Overweight and Obesity and Diet Modification, run by Beneo-Institute at 1 site in United Kingdom.
Trial summary
The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Diet Modification, Body Weight
- What is being tested?
- isomaltulose (Palatinose(TM) and Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2009to 30 Jun 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is healthy at the time of pre-examination
- Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight
- Subject is aged 18 - 60 years at the time of pre-examination
Who cannot join
- Person suffers from an acute or chronic disease
- Person has known dietary restrictions or allergies to Foods
- Intake of medications which interfere with body composition, appetite, satiety or food intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.
- Conditions
- Overweight and Obesity, Diet Modification, Body Weight
- Being tested
- isomaltulose (Palatinose(TM), Sucrose
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isomaltulose (Palatinose(TM)Other
isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
SucroseOther
sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Placebo comparator | Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose Receives: Other: Sucrose |
| Palatinose(TM) | Experimental | Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™) Receives: Other: isomaltulose (Palatinose(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change
Body weight Change over a 12-week period
Measured: 12 weeks
Secondary outcomes (4)
Body fat percentage
Body fat percentage measured using the BodPod
Measured: 12 weeks
postprandial respiratory quotient (RQ)
postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry
Measured: 120 minutes postprandial
BMI
Body mass index (kg/m2)
Measured: 12 weeks
Waist circumference
Waist circumference assessed using a measuring tape
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start20 Apr 2009
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
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 Overweight and 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652207
- Sponsor's protocol ID
- Beneo_OBU_101108Final
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maresch CC, Petry SF, Theis S, Bosy-Westphal A, Linn T. Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials. Nutrients. 2017 Apr 13;9(4):381. doi: 10.3390/nu9040381.
PubMed 28406437
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT03652207
- Acronym / sponsor ID
- Beneo_OBU_101108Final
- Conditions
- Overweight and Obesity, Diet Modification, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2009 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 29 Aug 2018 (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.
The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Placebo comparator | Other: SucroseTest products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose |
| Palatinose(TM) | Experimental | Other: isomaltulose (Palatinose(TM)Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is healthy at the time of pre-examination
- Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight
- Subject is aged 18 - 60 years at the time of pre-examination
Key exclusion criteria (3 listed)
- Person suffers from an acute or chronic disease
- Person has known dietary restrictions or allergies to Foods
- Intake of medications which interfere with body composition, appetite, satiety or food intake
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 |
|---|---|---|
| isomaltulose (Palatinose(TM)isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet | Other | Palatinose(TM) |
| Sucrosesucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet | Other | Sucrose |
Primary outcome
Body Weight Change
Time frame: 12 weeks
Body weight Change over a 12-week period
4 secondary outcomes
Body fat percentage
Time frame: 12 weeks
postprandial respiratory quotient (RQ)
Time frame: 120 minutes postprandial
BMI
Time frame: 12 weeks
Waist circumference
Time frame: 12 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 29 Aug 2018.
- Background: PubMed 28406437Maresch CC, Petry SF, Theis S, Bosy-Westphal A, Linn T. Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials. Nutrients. 2017 Apr 13;9(4):381. doi: 10.3390/nu9040381.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isomaltulose (Palatinose(TM) and Sucrose in people with Overweight and Obesity and Diet Modification, run by Beneo-Institute at 1 site in United Kingdom.
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 3 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Weight Change (time frame: 12 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 NCT03652207, 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 29 Aug 2018.