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

University of Copenhagen

Status: Completed

Conditions: Obesity

Treatments: Other: Inulin; Other: Whole milk; Other: Complete diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01913678

B307

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 23 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups, including a placebo group

Inulin

Active Comparator group

Description:

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.

Treatment:

Other: Complete diet

Other: Inulin

Whole milk

Active Comparator group

Description:

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.

Treatment:

Other: Whole milk

Other: Complete diet

Complete diet

Placebo Comparator group

Description:

The participants will be given all dietary items in their diet.

Treatment:

Other: Complete diet