Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

NCT ID: NCT01718418

Last Updated: 2013-05-08

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

EARLY_PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.

Detailed Description

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Conditions

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Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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+ ind.CHO + prebiotics

test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.

Group Type EXPERIMENTAL

test meal

Intervention Type OTHER

+ ind.CHO - prebiotics

test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.

Group Type EXPERIMENTAL

test meal

Intervention Type OTHER

- ind.CHO - prebiotics

reference: no ind. carbohydrates and no probiotic supplement

Group Type EXPERIMENTAL

reference

Intervention Type OTHER

Interventions

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test meal

Intervention Type OTHER

reference

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives

Exclusion Criteria

* gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Elin Johansson

MSc, post-graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Applied Nutrition and Food Chemistry, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.

Reference Type DERIVED
PMID: 28531784 (View on PubMed)

Other Identifiers

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Dnr2010/457

Identifier Type: -

Identifier Source: org_study_id

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