Gut Microbiome Based Analysis of High Protein High Fat Diet

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681664
• Other study ID #: NSP67
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2020
• Source: Center of Food and Fermentation Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• High fat diet
50 % fat

Locations

Country	Name	City	State
Estonia	Center of Food and Fermentation Technologies	Tallinn	Harjumaa

Sponsors (2)

Lead Sponsor	Collaborator
Center of Food and Fermentation Technologies	National Institute for Health Development, Estonia

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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