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

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ClinicalTrials.gov Identifier: NCT02347293
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Jonna Sandberg, Lund University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Other: High levels of indigestible carbohydrates Other: Low levels of indigestible carbohydrates Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: + ind. CHO
Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables
 Other: High levels of indigestible carbohydrates
Experimental: - ind. CHO
Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
 Other: Low levels of indigestible carbohydrates


Outcome Measures
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Primary Outcome Measures :
  1. Blood Glucose, levels of glucose in blood [ Time Frame: Postprandial 0-180 min after breakfast ]
  2. Insulin, levels of insulin in blood [ Time Frame: Postprandial 0-180 min after breakfast ]
  3. Appetite hormones, levels of Peptide YY (PYY) in blood [ Time Frame: Postprandial 0-180 min after breakfast ]
  4. Markers of colonic fermentation, levels of hydrogen in breath [ Time Frame: Postprandial 0-180 min after breakfast ]
  5. Inflammation markers, levels of Interleukin-6 (IL-6) in blood [ Time Frame: Postprandial 0-180 min after breakfast ]

Secondary Outcome Measures :
  1. Subjective satiety, as measured by VAS [ Time Frame: Postprandial 0-180 min after breakfast ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347293


Locations
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Sweden
Medicon Village
Lund, Sweden
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Anne Nilsson, PhD Lund University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonna Sandberg, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT02347293    
Other Study ID Numbers: Dnr2013/241b
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases