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

Obesity Clinical Trial

— FIAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913678
• Other study ID #: B307
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: April 19, 2017
• Start date: July 2013
• Est. completion date: July 3, 2014

Study information

• Verified date: April 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 3, 2014
• Est. primary completion date: July 3, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 23 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Frederiksberg	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FIAF blood concentration		21 days
Secondary	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
Secondary	Changes in microbiotic composition and characterization of gut microbiota, including metabolites		21 days
Secondary	Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)		21 days
Secondary	Changes in resting energy expenditure/lipid oxidation		21 days
Secondary	Changes in parameters involved in glucose metabolism		21 days
Secondary	Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels		21 days
Secondary	Changes in gene expression and protein concentration of genes/proteins related to obesity, lipid metabolism, adipocyte differentiation, hypoxia and FIAF signaling in adipose tissue		21 days
Secondary	Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines		21 days

External Links

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