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Completed

NCT Number: NCT02347293

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

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medicon Village

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High levels of indigestible carbohydrates

Other

Low levels of indigestible carbohydrates

Other

Primary outcomes

  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 outcomes

  1. Subjective satiety, as measured by VAS

    Time frame: Postprandial 0-180 min after breakfast

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2015
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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