Effects of Palatinose™ on Weight Management and Body Composition
The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2010
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedAugust 29, 2018
August 1, 2018
1.2 years
August 27, 2018
August 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Body Weight Change
Body weight Change over a 12-week period
12 weeks
Secondary Outcomes (4)
Body fat percentage
12 weeks
postprandial respiratory quotient (RQ)
120 minutes postprandial
BMI
12 weeks
Waist circumference
12 weeks
Study Arms (2)
Sucrose
PLACEBO COMPARATORTest products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose
Palatinose(TM)
EXPERIMENTALTest products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™)
Interventions
isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beneo-Institutelead
Study Sites (1)
Oxford Brookes University
Oxford, OX3 0BP, United Kingdom
Related Publications (1)
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.
PMID: 28406437BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 29, 2018
Study Start
April 20, 2009
Primary Completion
June 30, 2010
Study Completion
June 30, 2010
Last Updated
August 29, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share