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NCT Number: NCT01913678

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

23 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Frederiksberg, Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin

Other

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

Other

The participants will be given all dietary items in their diet with no additional products.

Whole milk

Other

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.

Primary outcomes

  1. Changes in FIAF blood concentration

    Time frame: 21 days

Secondary outcomes

  1. 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

  2. Changes in microbiotic composition and characterization of gut microbiota, including metabolites

    Time frame: 21 days

  3. Changes in short-chain fatty acid content of feces (butyrate, propionate and acetate)

    Time frame: 21 days

  4. Changes in resting energy expenditure/lipid oxidation

    Time frame: 21 days

  5. Changes in parameters involved in glucose metabolism

    Time frame: 21 days

  6. Changes in FIAF adipose tissue messenger ribonucleic acid (mRNA) levels

    Time frame: 21 days

  7. 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

  8. Changes in FIAF mRNA/protein expressed in or secreted from human intestinal cell lines

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods

Registry information

Acronym: FIAF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2013
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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