Gut Microbiome Based Analysis of High Protein High Fat Diet

Study Overview
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Brief Summary
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The aim of this study was to determine body mass reduction and microbiota composition change after the weight loss diet (50 % fat, 25 % proteins and 25 % carbohydrates).

Detailed Description
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For high fat group a total of 19 overweight/obese participants (14 females, 5 males, aged 25 to 43) with BMI of 28.9-44.4 kg/m2 were assigned to low-calorie low-carbohydrate high-fat weight loss diet for 4 weeks. As a control group, 58 subjects (39 females, 20 males, aged 24 to 55 years) were recruited and divided into 3 groups based on BMI: 18-25, 25-30, 30-39 kg/m2 (N=33, N=16, N=9, respectively). Inclusion criteria for participants included no previous history of gastrointestinal (GI) disease, no reported antibiotic use in preceding 3 months, or taking any medication known to alter bowel motility, no history of food allergies and not taking medications. Before the study all participants were informed about the study and participants were signed a written consent. At day 0 baseline samples and data were collected (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight). After collection of baseline samples subjects in the high fat group started diet plan for 4 weeks while control group contiunued their habitual diet. After the 4 week intervention period samples and data were collected again (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight).

Official Title
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Development of Methods and Algorithms to Design Diets Based on Gut Microbiome Analysis

Conditions
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Obesity

Intervention / Treatment
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* Other: High fat diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for obese group: BMI > 30 g/m2 Exclusion Criteria: antibiotic treatment within last three months; food restrictions due to allergies, any kind of food intolerance, veganism/vegetarianism or other extremes in food consumption practices; chronic illnesses; current pregnancy or breastfeeding travel to subtropical or tropical regions within one month before the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 % fat diet<br>In the high fat group the subjects were assigned to the diet containing in average 50 % fat, 25 % proteins and 25 % carbohydrates for four weeks. | Other: High fat diet<br>* 50 % fat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of body weight during 4 weeks high fat diet | Body weight was measured by calibrated scale before the study (baseline) and after the diet intervention (4 week) | Baseline and after 4 weeks | 
| Reduction of inflammation related bacteria in faecal microbiota | Bacterial composition was measured by 16S ribosomal sequencing at baseline and after the 4 weeks diet. The relative change of each bacterial taxon was calculated based on the abundance of the given bacteria at baseline and after 4 weeks high fat diet. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, ribosomal sequencing, obesity, bifidobacteria, Collinsella