Overview

This trial is active, not recruiting.

Condition obesity
Treatments inulin, complete diet, whole milk
Sponsor University of Copenhagen
Collaborator Arla Foods
Start date July 2013
End date May 2014
Trial size 20 participants
Trial identifier NCT01913678, B307

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
The 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.
inulin
The 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.
complete diet
The participants will be given all dietary items in their diet with no additional products.
(Active Comparator)
The 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.
complete diet
The participants will be given all dietary items in their diet with no additional products.
whole milk
The 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.
(Placebo Comparator)
The participants will be given all dietary items in their diet.
complete diet
The participants will be given all dietary items in their diet with no additional products.

Primary Outcomes

Measure
Changes in FIAF blood concentration
time frame: 21 days

Secondary Outcomes

Measure
Changes in blood lipid profile including triglyceride, free fatty acid, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), glycerol, butyrate
time frame: 21 days
Changes in microbiotic composition and characterization of gut microbiota, including metabolites
time frame: 21 days
Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)
time frame: 21 days
Changes in resting energy expenditure/lipid oxidation
time frame: 21 days
Changes in parameters involved in glucose metabolism
time frame: 21 days
Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels
time frame: 21 days
Changes in gene expression and protein concentration of genes/proteins related to obesity, lipid metabolism, adipocyte differentiation, hypoxia and FIAF signaling in adipose tissue
time frame: 21 days
Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines
time frame: 21 days

Eligibility Criteria

Male participants from 23 years up to 45 years old.

Inclusion Criteria: - Healthy males - Age: 23-45 - BMI: 25-32 kg/m2 - Body fat percentage (BFP) > 25 Exclusion Criteria: - Chronic diseases (known diabetes, cardiovascular disease (CVD), Intestinal Bowel Disease and other chronic diseases likely to affect the results of the present study) - Milk allergy/lactose intolerance - Intolerance towards inulin - Fasting glucose ≥7.0 mmol/l or non-fasting glucose ≥ 11 mmol/l* - Use of antibiotics 2 months before commencement of study - Use of dietary supplements incl. multivitamins during run-in and the entire study period - Smoking - Elite athletes (>10 hours of strenuous physical activity per week) - Use of prescription medicine which could affect the results of the present study, including systemic glucocorticoids - Use of lipid-lowering agents or medication with contraindications for a high fat diet - Blood pressure > 140/90 mmHg - Blood donation <1 month before study commencement and during study period - Simultaneous participation in other clinical studies - Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff

Additional Information

Official title The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
Principal investigator Arne Astrup, Prof., MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Copenhagen.