NCT03423381

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

December 29, 2017

Last Update Submit

March 21, 2019

Conditions

Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Blood glucose regulation

    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.

    0-14 h after intake

Secondary Outcomes (11)

  • serum insulin

    0-14 h after intake

  • gut microbiota composition

    first stool delivered from14 h after intake

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

    0-14 h after intake

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

    0-14 h after intake

  • plasma GLP-2

    0-14 h after intake

  • +6 more secondary outcomes

Other Outcomes (4)

  • Subjective appetite sensations

    0-14 h after intake

  • mood (valence and activity)

    0-14 h after intake

  • Energy intake

    4 h after intake of a test product or the control product

  • +1 more other outcomes

Study Arms (6)

Cereal product 1

EXPERIMENTAL

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 product 2

EXPERIMENTAL

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 product 3

EXPERIMENTAL

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 product 4

EXPERIMENTAL

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 product 5

EXPERIMENTAL

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

Control product

PLACEBO COMPARATOR

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

Interventions

Cereal product 1OTHER

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

Cereal product 1
Cereal product 2OTHER

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

Cereal product 2
Cereal product 3OTHER

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

Cereal product 3
Cereal product 4OTHER

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

Cereal product 4
Cereal product 5OTHER

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

Cereal product 5
Control productOTHER

A cereal based product with low concentrations of df

Control product

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

Location

Related Publications (6)

  • Nilsson AC, Ostman EM, Knudsen KE, Holst JJ, Bjorck IM. A cereal-based evening meal rich in indigestible carbohydrates increases plasma butyrate the next morning. J Nutr. 2010 Nov;140(11):1932-6. doi: 10.3945/jn.110.123604. Epub 2010 Sep 1.

    PMID: 20810606BACKGROUND

  • Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.

    PMID: 26259632BACKGROUND

  • Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Bjorck I, Backhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6.

    PMID: 26552345BACKGROUND

  • Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.

    PMID: 26990559BACKGROUND

  • Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.

    PMID: 28431559BACKGROUND

  • Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.

    PMID: 18356328BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anne Nilsson, PhD

    Food Technology, engineering, and Nutrition, LTH, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD

Study Record Dates

First Submitted

December 29, 2017

First Posted

February 6, 2018

Study Start

May 30, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)