Clinical Trials Directory

Trials / Completed

CompletedNCT01913678

The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
Male
Age
23 Years – 45 Years
Healthy volunteers
Accepted

Summary

The objective of this study is to investigate whether intake of a diet with a high content of butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet. Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In addition, the correlation between FIAF blood concentrations and resting energy expenditure, blood lipid profile and gut microbiota composition will be investigated. Furthermore, this study will investigate whether the source of FIAF can be determined. To this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal water samples will be carried out. The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of 3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the order of interventions. Before and after each intervention period, blood samples will be collected and the participants will have their resting metabolic rate measured. At the end of each intervention period, the participants will collect feces for 5 consecutive days. In addition, adipose tissue biopsies will be taken after each intervention period.

Conditions

Interventions

TypeNameDescription
OTHERInulinThe participants will be given all dietary items in their diet. In the inulin arm, approximately 15 grams of inulin will be included in the diet.
OTHERComplete dietThe participants will be given all dietary items in their diet with no additional products.
OTHERWhole milkThe participants will be given all dietary items in their diet. In the whole milk arm, approximately 1 liter of whole milk will be included in the diet.

Timeline

Start date
2013-07-01
Primary completion
2014-07-03
Completion
2014-07-03
First posted
2013-08-01
Last updated
2017-04-20

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01913678. Inclusion in this directory is not an endorsement.