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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
Center of Food and Fermentation Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring microbiome, ribosomal sequencing, obesity, bifidobacteria, Collinsella

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 30, 2020
Last Updated
December 19, 2020
Sponsor
Center of Food and Fermentation Technologies
Collaborators
National Institute for Health Development, Estonia
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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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