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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

Tracking Information
First Submitted Date  ICMJE December 29, 2017
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE May 30, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • 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.
  • gut microbiota composition [ Time Frame: first stool delivered from14 h after intake ]
    effects on gut microbiota composition after intake of prebiotics
  • 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
  • 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
  • plasma GLP-2 [ Time Frame: 0-14 h after intake ]
    gut hormone involved in gut mucosa integrity
  • plasma SCFA (short-chain fatty acid) [ Time Frame: 0-14 h after intake ]
    colonic fermentation metabolites
  • blood lipids [ Time Frame: 0-14 h after intake ]
    cholesterol and free fatty acids in plasma
  • plasma adiponectin [ Time Frame: 0-14 h after intake ]
    hormone involved in metabolic regulation
  • 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
  • plasma neurotensin [ Time Frame: 0-14 h after intake ]
    a neuro peptide peptides involved in appetite and metabolic regulation
  • plasma Nesfatin-1 [ Time Frame: 0-14 h after intake ]
    a neuro peptide that participates in the regulation of hunger and fat storage.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2018)
  • Subjective appetite sensations [ Time Frame: 0-14 h after intake ]
    determined with VAS (visual analogue scale) scales (0-100 mm)
  • mood (valence and activity) [ Time Frame: 0-14 h after intake ]
    determined with VAS scales (0-100 mm)
  • 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
  • breath hydrogen concentrations [ Time Frame: 0-14 h after intake ]
    indicator of gut fermentation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dietary Fibre and Metabolic Benefits
Official Title  ICMJE Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover randomised
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Glucose Tolerance
Intervention  ICMJE
  • Other: Cereal product 1
    Cereal products based on rye, barley, wheat, oat, and corn
  • Other: Cereal product 2
    Cereal products based on rye, barley, wheat, oat, and corn
  • Other: Cereal product 3
    Cereal products based on rye, barley, wheat, oat, and corn
  • Other: Cereal product 4
    Cereal products based on rye, barley, wheat, oat, and corn
  • Other: Cereal product 5
    Cereal products based on rye, barley, wheat, oat, and corn
  • Other: Control product
    A cereal based product with low concentrations of df
Study Arms  ICMJE
  • 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.
    Intervention: Other: Cereal product 1
  • 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.
    Intervention: Other: Cereal product 2
  • 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.
    Intervention: Other: Cereal product 3
  • 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.
    Intervention: Other: Cereal product 4
  • 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.
    Intervention: Other: Cereal product 5
  • 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.
    Intervention: Other: Control product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
20
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423381
Other Study ID Numbers  ICMJE 2017-03575
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anne Nilsson, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE
  • Vinnova
  • Öste Venture AB
Investigators  ICMJE
Principal Investigator: Anne Nilsson, PhD Food Technology, engineering, and Nutrition, LTH, Lund University
PRS Account Lund University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP