Back to resultsEffects of Palatinose™ on Weight Management and Body Composition
Primary Purpose
Overweight and Obesity, Diet Modification, Body Weight
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
isomaltulose (Palatinose(TM)
Sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Oxford Brookes University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sucrose
Palatinose(TM)
Arm Description
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™)
Outcomes
Primary Outcome Measures
Body Weight Change
Body weight Change over a 12-week period
Secondary Outcome Measures
Body fat percentage
Body fat percentage measured using the BodPod
postprandial respiratory quotient (RQ)
postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry
BMI
Body mass index (kg/m2)
Waist circumference
Waist circumference assessed using a measuring tape
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03652207
Brief Title
Effects of Palatinose™ on Weight Management and Body Composition
Official Title
The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2009 (Actual)
Primary Completion Date
June 30, 2010 (Actual)
Study Completion Date
June 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beneo-Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Diet Modification, Body Weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sucrose
Arm Type
Placebo Comparator
Arm Description
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose
Arm Title
Palatinose(TM)
Arm Type
Experimental
Arm Description
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™)
Intervention Type
Other
Intervention Name(s)
isomaltulose (Palatinose(TM)
Intervention Description
isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
Intervention Type
Other
Intervention Name(s)
Sucrose
Intervention Description
sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
Primary Outcome Measure Information:
Title
Body Weight Change
Description
Body weight Change over a 12-week period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
Body fat percentage measured using the BodPod
Time Frame
12 weeks
Title
postprandial respiratory quotient (RQ)
Description
postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry
Time Frame
120 minutes postprandial
Title
BMI
Description
Body mass index (kg/m2)
Time Frame
12 weeks
Title
Waist circumference
Description
Waist circumference assessed using a measuring tape
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Oxford Brookes University
City
Oxford
ZIP/Postal Code
OX3 0BP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28406437
Citation
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.
Results Reference
background
Learn more about this trial
Effects of Palatinose™ on Weight Management and Body Composition
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