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Effects of Palatinose™ on Weight Management and Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652207
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Beneo-Institute

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Diet Modification Body Weight Other: isomaltulose (Palatinose(TM) Other: Sucrose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
Actual Study Start Date : April 20, 2009
Actual Primary Completion Date : June 30, 2010
Actual Study Completion Date : June 30, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Sucrose

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




Primary Outcome Measures :
  1. Body Weight Change [ Time Frame: 12 weeks ]
    Body weight Change over a 12-week period


Secondary Outcome Measures :
  1. Body fat percentage [ Time Frame: 12 weeks ]
    Body fat percentage measured using the BodPod

  2. postprandial respiratory quotient (RQ) [ Time Frame: 120 minutes postprandial ]
    postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry

  3. BMI [ Time Frame: 12 weeks ]
    Body mass index (kg/m2)

  4. Waist circumference [ Time Frame: 12 weeks ]
    Waist circumference assessed using a measuring tape



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652207


Locations
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United Kingdom
Oxford Brookes University
Oxford, United Kingdom, OX3 0BP
Sponsors and Collaborators
Beneo-Institute

Publications:
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Responsible Party: Beneo-Institute
ClinicalTrials.gov Identifier: NCT03652207    
Other Study ID Numbers: Beneo_OBU_101108Final
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Overweight
Signs and Symptoms