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Completed

NCT Number: NCT03652207

Effects of Palatinose™ on Weight Management and Body Composition

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.

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Key information

Conditions

Overweight and Obesity Body Weight Diet Modification Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Brookes University

Oxford, OX3 0BP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isomaltulose (Palatinose(TM)

Other

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

Sucrose

Other

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

Primary outcomes

  1. Body Weight Change

    Time frame: 12 weeks

    Body weight Change over a 12-week period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Registry information

Official study title

The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 29, 2018
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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