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Completed

NCT Number: NCT03423381

Dietary Fibre and Metabolic Benefits

The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

About this study

The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adults
  • BMI<30
  • non smokers
  • consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion criteria

  • fasting blood glucose >6.1 mmol/L
  • known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Treatment and study plan

Cereal product 1

Other

Cereal products based on rye, barley, wheat, oat, and corn

Cereal product 2

Other

Cereal products based on rye, barley, wheat, oat, and corn

Cereal product 3

Other

Cereal products based on rye, barley, wheat, oat, and corn

Cereal product 4

Other

Cereal products based on rye, barley, wheat, oat, and corn

Cereal product 5

Other

Cereal products based on rye, barley, wheat, oat, and corn

Control product

Other

A cereal based product with low concentrations of df

Primary outcomes

  1. Blood glucose regulation

    Time frame: 0-14 h after intake

    Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.

Secondary outcomes

  1. serum insulin

    Time frame: 0-14 h after intake

    Postprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.

  2. gut microbiota composition

    Time frame: first stool delivered from14 h after intake

    effects on gut microbiota composition after intake of prebiotics

  3. plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin

    Time frame: 0-14 h after intake

    Gastro-intestinale hormones involved in appetite and metabolic regulation

  4. plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)

    Time frame: 0-14 h after intake

    Inflammatory markers in blood

  5. plasma GLP-2

    Time frame: 0-14 h after intake

    gut hormone involved in gut mucosa integrity

  6. plasma SCFA (short-chain fatty acid)

    Time frame: 0-14 h after intake

    colonic fermentation metabolites

  7. blood lipids

    Time frame: 0-14 h after intake

    cholesterol and free fatty acids in plasma

  8. plasma adiponectin

    Time frame: 0-14 h after intake

    hormone involved in metabolic regulation

  9. plasma BDNF (Brain-derived neurotrophic factor)

    Time frame: 0-14 h after intake

    signal protein important for brain functions, but also involved in metabolic regulation

  10. plasma neurotensin

    Time frame: 0-14 h after intake

    a neuro peptide peptides involved in appetite and metabolic regulation

  11. plasma Nesfatin-1

    Time frame: 0-14 h after intake

    a neuro peptide that participates in the regulation of hunger and fat storage.

Other outcomes

  1. Subjective appetite sensations

    Time frame: 0-14 h after intake

    determined with VAS (visual analogue scale) scales (0-100 mm)

  2. mood (valence and activity)

    Time frame: 0-14 h after intake

    determined with VAS scales (0-100 mm)

  3. Energy intake

    Time frame: 4 h after intake of a test product or the control product

    ad libitum intake at a second meal after intake of test products

  4. breath hydrogen concentrations

    Time frame: 0-14 h after intake

    indicator of gut fermentation

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Vinnova
  • Öste Venture AB

Registry information

Official study title

Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2018
Registry last updated
Mar 25, 2019

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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