Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety

Obesity Clinical Trial

Official title:

Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347293
• Other study ID #: Dnr2013/241b
• Status: Completed
• Phase: Phase 0
• First received: January 15, 2015
• Last updated: May 26, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• 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, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• 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

• Food allergies e.g. lactose-, gluten intolerance

• Metabolic disorder e.g. diabetes

• Tobacco/snuff users

• No antibiotic or probiotic intake 2 weeks prior 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:
• High levels of indigestible carbohydrates

• Low levels of indigestible carbohydrates

Locations

Country	Name	City	State
Sweden	Medicon Village	Lund

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, levels of glucose in blood		Postprandial 0-180 min after breakfast	No
Primary	Insulin, levels of insulin in blood		Postprandial 0-180 min after breakfast	No
Primary	Appetite hormones, levels of Peptide YY (PYY) in blood		Postprandial 0-180 min after breakfast	No
Primary	Markers of colonic fermentation, levels of hydrogen in breath		Postprandial 0-180 min after breakfast	No
Primary	Inflammation markers, levels of Interleukin-6 (IL-6) in blood		Postprandial 0-180 min after breakfast	No
Secondary	Subjective satiety, as measured by VAS		Postprandial 0-180 min after breakfast	No