Effects of Palatinose™ on Weight Management and Body Composition

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652207
• Other study ID #: Beneo_OBU_101108Final
• Status: Completed
• Phase: N/A
• Start date: April 20, 2009
• Est. completion date: June 30, 2010

Study information

• Verified date: August 2018
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 30, 2010
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diet Modification
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes University	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Beneo-Institute

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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). pii: E381. doi: 10.3390/nu9040381. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Change	Body weight Change over a 12-week period	12 weeks
Secondary	Body fat percentage	Body fat percentage measured using the BodPod	12 weeks
Secondary	postprandial respiratory quotient (RQ)	postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry	120 minutes postprandial
Secondary	BMI	Body mass index (kg/m2)	12 weeks
Secondary	Waist circumference	Waist circumference assessed using a measuring tape	12 weeks