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

Early Phase 1

Completed

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Other: Low levels of indigestible carbohydrates; Other: High levels of indigestible carbohydrates

• Registration Number: NCT02347293
• Lead Sponsor: Lund University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
- ind. CHO	Low levels of indigestible carbohydrates	Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
+ ind. CHO	High levels of indigestible carbohydrates	Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables

Primary Outcome Measures

Name	Time	Method
Appetite hormones, levels of Peptide YY (PYY) in blood	Postprandial 0-180 min after breakfast
Blood Glucose, levels of glucose in blood	Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood	Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath	Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood	Postprandial 0-180 min after breakfast

Secondary Outcome Measures

Name	Time	Method
Subjective satiety, as measured by VAS	Postprandial 0-180 min after breakfast

Trial Locations

Locations (1)

Medicon Village; 🇸🇪 Lund, Sweden