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Gut Microbiome Based Analysis of High Protein High Fat Diet

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04681664
Enrollment
78
Registered
2020-12-23
Start date
2017-04-01
Completion date
2017-11-30
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

microbiome, ribosomal sequencing, obesity, bifidobacteria, Collinsella

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).

Interventions

50 % fat

Sponsors

National Institute for Health Development, Estonia
CollaboratorOTHER_GOV
Center of Food and Fermentation Technologies
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Decrease of body weight during 4 weeks high fat dietBaseline and after 4 weeksBody weight was measured by calibrated scale before the study (baseline) and after the diet intervention (4 week)
Reduction of inflammation related bacteria in faecal microbiota4 weeksBacterial 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.

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026