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Trial record 52 of 54 for:    barley

Dietary Fibre and Metabolic Benefits

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ClinicalTrials.gov Identifier: NCT03423381
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
Vinnova
Öste Venture AB
Information provided by (Responsible Party):
Anne Nilsson, Lund University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Glucose Tolerance Other: Cereal product 1 Other: Cereal product 2 Other: Cereal product 3 Other: Cereal product 4 Other: Cereal product 5 Other: Control product Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover randomised
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: Cereal product 1
Cereal based müsli no. 1, made from typical Swedish cereals. All experimental products have different types and amounts of dietary fibre (df). The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Cereal product 1
Cereal products based on rye, barley, wheat, oat, and corn

Experimental: Cereal product 2
Cereal based muesli no. 2 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Cereal product 2
Cereal products based on rye, barley, wheat, oat, and corn

Experimental: Cereal product 3
Cereal based muesli no.3 made from typical Swedish cereals. All experimental products have different types and amounts of df.The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Cereal product 3
Cereal products based on rye, barley, wheat, oat, and corn

Experimental: Cereal product 4
Cereal based muesli no. 4 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Cereal product 4
Cereal products based on rye, barley, wheat, oat, and corn

Experimental: Cereal product 5
Cereal based muesli no. 5 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Cereal product 5
Cereal products based on rye, barley, wheat, oat, and corn

Placebo Comparator: Control product
A cereal based product with low concentrations of df. The control portion is consumed as a single evening meal prior to determinations of test variables in the morning.
Other: Control product
A cereal based product with low concentrations of df




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423381


Locations
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Sweden
Food Technology, engineering and Nutrition, LTH, Lund University
Lund, Sweden, 22100
Sponsors and Collaborators
Lund University
Vinnova
Öste Venture AB
Investigators
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Principal Investigator: Anne Nilsson, PhD Food Technology, engineering, and Nutrition, LTH, Lund University

Publications:

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Responsible Party: Anne Nilsson, Associate professor, PhD, Lund University
ClinicalTrials.gov Identifier: NCT03423381     History of Changes
Other Study ID Numbers: 2017-03575
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No