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OpenTrials
Completed

NCT Number: NCT01718431

Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 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

  • BMI 19-28 kg/m2

Exclusion criteria

  • gastrointestinal diseases
  • metabolic disorders
  • tobacco/snuff user
  • antibiotic/probiotic treatment

Treatment and study plan

Test meal

Other

Reference meal

Other

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of the test meal

    Time frame: Post-prandially after breakfast, 0-150 min

    The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.

Secondary outcomes

  1. Cognitive performance

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

    The cognitive performance of the test subjects is measured to investigate work memory and specific attention.

  2. Subjective satiety

    Time frame: post-prandially after breakfast, 0-150 min

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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
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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