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Completed

NCT Number: NCT04681664

Gut Microbiome Based Analysis of High Protein High Fat Diet

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).

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Food and Fermentation Technologies

Tallinn, Harju, 12618, Estonia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High fat diet

Other

50 % fat

Primary outcomes

  1. Decrease of body weight during 4 weeks high fat diet

    Time frame: Baseline and after 4 weeks

    Body weight was measured by calibrated scale before the study (baseline) and after the diet intervention (4 week)

  2. Reduction of inflammation related bacteria in faecal microbiota

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Center of Food and Fermentation Technologies

Other

Collaborators

  • National Institute for Health Development, Estonia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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