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

Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718418

Enrollment

Registered

2012-10-31

Start date

2012-09-30

Completion date

2012-12-31

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

Brief summary

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.

Interventions

OTHERtest meal

OTHERreference

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.	Post-prandially after breakfast, 0-210 min	Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.

Secondary

Measure	Time frame	Description
voluntary energy intake	Post-prandially after breakfast, 0-210 min	Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
Subjective satiety	post-prandially after breakfast, 0-210 min	The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
Differences in gut microbiota	Faecal samples are collected after 14 days intake of test- and reference product	The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026