Gut Microbiome Based Analysis of High Protein High Fat Diet

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: High fat diet

• Registration Number: NCT04681664
• Lead Sponsor: Center of Food and Fermentation Technologies

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).

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-11-30
• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-19
• Last Update Submitted: 2020-12-19
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50 % fat diet	High fat diet	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.

Primary Outcome Measures

Name	Time	Method
Reduction of inflammation related bacteria in faecal microbiota	4 weeks	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.
Decrease of body weight during 4 weeks high fat diet	Baseline and after 4 weeks	Body weight was measured by calibrated scale before the study (baseline) and after the diet intervention (4 week)

Trial Locations

Locations (1)

Center of Food and Fermentation Technologies; 🇪🇪 Tallinn, Harjumaa, Estonia