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Completed

NCT Number: NCT01718418

Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.

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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

Applied Nutrition and Food Chemistry, Lund University

Lund, SE-221 00, 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, for women: hormon based contraceptives

Exclusion criteria

  • gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians

Treatment and study plan

Test meal

Other

reference

Other

Primary outcomes

  1. Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.

    Time frame: Post-prandially after breakfast, 0-210 min

    Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.

Secondary outcomes

  1. voluntary energy intake

    Time frame: Post-prandially after breakfast, 0-210 min

    Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.

  2. Subjective satiety

    Time frame: post-prandially after breakfast, 0-210 min

    The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.

  3. Differences in gut microbiota

    Time frame: Faecal samples are collected after 14 days intake of test- and reference product

    The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2012
Registry last updated
May 8, 2013

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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