Effects of Dietary Fibre on Glucose Metabolism and Satiety

Obesity Clinical Trial

Official title:

Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093481
• Other study ID #: Dnr2013/241
• Status: Completed
• Phase: Phase 0
• First received: March 10, 2014
• Last updated: June 25, 2014
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

• Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Other:
• Test meal

• Reference

• Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
• No priming
The reference or test meal was eaten 1 days prior to measurements of variables.

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund Univeristy	Lund	SE

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	The test products are both ingested one day and three days prior to measurements of variables.	Postprandial 0-180 min after breakfast	No
Primary	Insulin	The test products are both ingested one day and three days prior to measurements of variables.	Postprandial 0-180 min after breakfast	No
Primary	Appetite hormones	The test products are both ingested one day and three days prior to measurements of variables.	Postprandial 0-180 min after breakfast	No
Primary	Markers of colonic fermentation and inflammation	The test products are both ingested one day and three days prior to measurements of variables.	Postprandial 0-180 min after breakfast	No
Secondary	Subjective satiety	The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.	Postprandial 0-180 min after breakfast	No