Effects of Palatinose™ on Weight Management and Body Composition

NCT ID: NCT03652207

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-20

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity Diet Modification Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sucrose

Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose

Group Type PLACEBO_COMPARATOR

Sucrose

Intervention Type OTHER

sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet

Palatinose(TM)

Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™)

Group Type EXPERIMENTAL

isomaltulose (Palatinose(TM)

Intervention Type OTHER

isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet

Interventions

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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

Intervention Type OTHER

Sucrose

sucrose 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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beneo-Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford Brookes University

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28406437 (View on PubMed)

Other Identifiers

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Beneo_OBU_101108Final

Identifier Type: -

Identifier Source: org_study_id

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