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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonna Sandberg, Lund University
ClinicalTrials.gov Identifier:
NCT02347293
First received: January 15, 2015
Last updated: May 26, 2015
Last verified: May 2015
  Purpose
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 Intervention Phase
Obesity
Metabolic Syndrome
Other: High levels of indigestible carbohydrates
Other: Low levels of indigestible carbohydrates
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Lund University:

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

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

Enrollment: 21
Study Start Date: October 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02347293

Locations
Sweden
Medicon Village
Lund, Sweden
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anne Nilsson, PhD Lund University
  More Information

Responsible Party: Jonna Sandberg, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT02347293     History of Changes
Other Study ID Numbers: Dnr2013/241b
Study First Received: January 15, 2015
Last Updated: May 26, 2015

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2017