The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
FIAF
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jul 2013
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2014
CompletedApril 20, 2017
April 1, 2017
1 year
July 30, 2013
April 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in FIAF blood concentration
21 days
Secondary Outcomes (8)
Changes in blood lipid profile including triglyceride, free fatty acid, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), glycerol, butyrate
21 days
Changes in microbiotic composition and characterization of gut microbiota, including metabolites
21 days
Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)
21 days
Changes in resting energy expenditure/lipid oxidation
21 days
Changes in parameters involved in glucose metabolism
21 days
- +3 more secondary outcomes
Study Arms (3)
Inulin
ACTIVE COMPARATORThe 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.
Whole milk
ACTIVE COMPARATORThe 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
PLACEBO COMPARATORThe participants will be given all dietary items in their diet.
Interventions
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.
The participants will be given all dietary items in their diet with no additional products.
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.
Eligibility Criteria
You may qualify if:
- Healthy males
- Age: 23-45
- BMI: 25-32 kg/m2
- Body fat percentage (BFP) \> 25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Arla Foodscollaborator
Study Sites (1)
Department of Nutrition, Exercise and Sports
Frederiksberg, Copenhagen, 1958, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arne Astrup, Prof., MD
Department of Nutrition, Exercise and Sports
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 1, 2013
Study Start
July 1, 2013
Primary Completion
July 3, 2014
Study Completion
July 3, 2014
Last Updated
April 20, 2017
Record last verified: 2017-04