Dietary Fibre and Metabolic Benefits

NCT ID: NCT03423381

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover randomised
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Cereal product 1

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cereal product 2

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cereal product 3

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cereal product 4

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cereal product 5

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Control product

Intervention Type OTHER

A cereal based product with low concentrations of df

Interventions

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Cereal product 1

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

Intervention Type OTHER

Cereal product 2

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

Intervention Type OTHER

Cereal product 3

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

Intervention Type OTHER

Cereal product 4

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

Intervention Type OTHER

Cereal product 5

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

Intervention Type OTHER

Control product

A cereal based product with low concentrations of df

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vinnova

OTHER_GOV

Sponsor Role collaborator

Öste Venture AB

UNKNOWN

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Anne Nilsson

Associate professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Food Technology, engineering and Nutrition, LTH, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 20810606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26259632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26552345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26990559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28431559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18356328 (View on PubMed)

Other Identifiers

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2017-03575

Identifier Type: -

Identifier Source: org_study_id

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