ObesityFIAFNCT01913678
The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
A study testing Inulin, Complete diet and Whole milk in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Inulin, Complete diet and Whole milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to 3 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age: 23-45
- BMI: 25-32 kg/m2
- Body fat percentage (BFP) > 25
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Frederiksberg, Copenhagen, 1958
About this study
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
- Obesity
- Being tested
- Inulin, Complete diet, Whole milk
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinOther
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 dietOther
The participants will be given all dietary items in their diet with no additional products.
Whole milkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inulin | 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. Receives: Other: Inulin; Other: Complete diet |
| Whole milk | 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. Receives: Other: Complete diet; Other: Whole milk |
| Complete diet | Placebo comparator | The participants will be given all dietary items in their diet. Receives: Other: Complete diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FIAF blood concentration
Measured: 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
Measured: 21 days
Changes in microbiotic composition and characterization of gut microbiota, including metabolites
Measured: 21 days
Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)
Measured: 21 days
Changes in resting energy expenditure/lipid oxidation
Measured: 21 days
Changes in parameters involved in glucose metabolism
Measured: 21 days
Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels
Measured: 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
Measured: 21 days
Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Prof., MD, Principal investigator, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913678
- Sponsor's protocol ID
- B307
- Acronym
- FIAF
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2013
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
- ClinicalTrials.gov ID
- NCT01913678
- Acronym / sponsor ID
- FIAF / B307
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Jul 2013
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inulin | Active comparator | Other: Inulin, Other: Complete dietThe 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 comparator | Other: Complete diet, Other: Whole 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. |
| Complete diet | Placebo comparator | Other: Complete dietThe participants will be given all dietary items in their diet. |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Age: 23-45
- BMI: 25-32 kg/m2
- Body fat percentage (BFP) > 25
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinThe 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 |
| Complete dietThe participants will be given all dietary items in their diet with no additional products. | Other | Complete diet, Inulin, Whole milk |
| Whole 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. | Other | Whole milk |
Primary outcome
Changes in FIAF blood concentration
Time frame: 21 days
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Prof., MD principal investigator
Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin, Complete diet and Whole milk in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FIAF blood concentration (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.