NCT04681664

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

November 30, 2020

Last Update Submit

December 19, 2020

Conditions

Obesity

Keywords

microbiomeribosomal sequencingobesitybifidobacteriaCollinsella

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

50 % fat diet

EXPERIMENTAL

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

Interventions

High fat dietOTHER

50 % fat

50 % fat diet

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 30 g/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Food and Fermentation Technologies

Tallinn, Harju, 12618, Estonia

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 23, 2020

Study Start

April 1, 2017

Primary Completion

September 30, 2017

Study Completion

November 30, 2017

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)