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

April 19, 2017 updated by: Arne Astrup, University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Frederiksberg, Copenhagen, Denmark, 1958
        • Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: 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.
Other: Complete diet
The participants will be given all dietary items in their diet with no additional products.
ACTIVE_COMPARATOR: 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.
Other: Complete diet
The participants will be given all dietary items in their diet with no additional products.
Other: 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: Complete diet
The participants will be given all dietary items in their diet.
Other: Complete diet
The participants will be given all dietary items in their diet with no additional products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in FIAF blood concentration
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
21 days
Changes in microbiotic composition and characterization of gut microbiota, including metabolites
Time Frame: 21 days
21 days
Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)
Time Frame: 21 days
21 days
Changes in resting energy expenditure/lipid oxidation
Time Frame: 21 days
21 days
Changes in parameters involved in glucose metabolism
Time Frame: 21 days
21 days
Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels
Time Frame: 21 days
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
21 days
Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Arla Foods

Investigators

  • Principal Investigator: Arne Astrup, Prof., MD, Department of Nutrition, Exercise and Sports

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

July 3, 2014

Study Completion (ACTUAL)

July 3, 2014

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • B307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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