Gut Microbiome Based Analysis of High Protein High Fat Diet
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
High fat diet
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring microbiome, ribosomal sequencing, obesity, bifidobacteria, Collinsella
Eligibility Criteria
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.
Sites / Locations
- Center of Food and Fermentation Technologies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
50 % fat diet
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04681664
First Posted
November 30, 2020
Last Updated
December 19, 2020
Sponsor
Center of Food and Fermentation Technologies
Collaborators
National Institute for Health Development, Estonia
1. Study Identification
Unique Protocol Identification Number
NCT04681664
Brief Title
Gut Microbiome Based Analysis of High Protein High Fat Diet
Official Title
Development of Methods and Algorithms to Design Diets Based on Gut Microbiome Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Food and Fermentation Technologies
Collaborators
National Institute for Health Development, Estonia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
microbiome, ribosomal sequencing, obesity, bifidobacteria, Collinsella
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 % fat diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High fat diet
Intervention Description
50 % fat
Primary Outcome Measure Information:
Title
Decrease of body weight during 4 weeks high fat diet
Description
Body weight was measured by calibrated scale before the study (baseline) and after the diet intervention (4 week)
Time Frame
Baseline and after 4 weeks
Title
Reduction of inflammation related bacteria in faecal microbiota
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Center of Food and Fermentation Technologies
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
12618
Country
Estonia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gut Microbiome Based Analysis of High Protein High Fat Diet
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