Effects of Palatinose™ on Weight Management and Body Composition

August 27, 2018 updated by: Beneo-Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 0BP
        • Oxford Brookes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Sucrose
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose
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
EXPERIMENTAL: Palatinose(TM)
Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight Change
Time Frame: 12 weeks
Body weight Change over a 12-week period
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat percentage
Time Frame: 12 weeks
Body fat percentage measured using the BodPod
12 weeks
postprandial respiratory quotient (RQ)
Time Frame: 120 minutes postprandial
postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry
120 minutes postprandial
BMI
Time Frame: 12 weeks
Body mass index (kg/m2)
12 weeks
Waist circumference
Time Frame: 12 weeks
Waist circumference assessed using a measuring tape
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beneo-Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2009

Primary Completion (ACTUAL)

June 30, 2010

Study Completion (ACTUAL)

June 30, 2010

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beneo_OBU_101108Final

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Body Weight

Clinical Trials on Sucrose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe