Gut Microbiome Based Analysis of High Protein High Fat Diet

Center of Food and Fermentation Technologies

Status: Completed

Conditions: Obesity

Treatments: Other: High fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04681664

NSP67

Details and patient eligibility

About

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).

Full 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).

Enrollment: 78 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

50 % fat diet

Experimental group

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.

Treatment:

Other: High fat diet