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

L

Lund University

Status and phase

Completed
Early Phase 1

Conditions

Obesity
Metabolic Syndrome

Treatments

Other: reference
Other: test meal

Study type

Interventional

Funder types

Other

Identifiers

NCT01718418
Dnr2010/457

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

21 participants in 3 patient groups

+ ind.CHO + prebiotics
Experimental group
Description:
test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.
Treatment:
Other: test meal
+ ind.CHO - prebiotics
Experimental group
Description:
test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.
Treatment:
Other: test meal
- ind.CHO - prebiotics
Experimental group
Description:
reference: no ind. carbohydrates and no probiotic supplement
Treatment:
Other: reference

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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