Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-29

Study Completion Date

2018-03-13

Brief Summary

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The present study aimed to investigate the changes produced in gut microbiota by a very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics is able to modulate gut microbiota diversity and composition and its association with gut permeability and inflammation

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Detailed Description

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All participants followed a very-low-calorie ketogenic diet according to a commercial weight loss program (Pronokal method), which includes lifestyle and behavioural modification support. This method is based on high-biological-value protein preparations which contained 15 g protein, 4 g carbohydrates, 3 g fat and 50 mg docosahexaenoic acid, and provided 90-110 kcal. The study was divided in two phases. The first phase consists of a very-low-calorie ketogenic diet (600-800 kcal/day), low in carbohydrates and lipids. Throughout this ketogenic phase, supplements of vitamins and minerals such as K, Na, Mg, Ca and omega-3 fatty acids were provided. In this study the ketogenic step was maintained for 2 months. Then, the patients started a low-calorie diet (800-1500 kcal/day) which lasted two months.

During the first phase consisting of a very-low-calorie ketogenic diet, subjects were randomly divided into two groups, the treatment group who received synbiotic supplementation as capsules, a complex of B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber (synbiotic 1) and the control group who received a placebo. During the second phase consisting of a low-calorie diet, the treatment group received synbiotic supplementation as capsules consisting of B. animalis subsp. lactis and prebiotics fiber (synbiotic 2) (synbiotic1 + synbiotic 2 group), while the control group was divided into two groups: one continued receiving a placebo (control group) whilst the other group received synbiotic 2 (placebo + synbiotic2 group).

Conditions

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Weight Loss Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Placebo

Very low calorie ketogenic diet followed by low calorie diet

Group Type PLACEBO_COMPARATOR

Diet

Intervention Type OTHER

Very low calorie ketogenic diet followed by low calorie diet

Synbiotic1+synbiotic2

Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Very low calorie ketogenic diet followed by low calorie diet

Synbiotic1

Intervention Type DIETARY_SUPPLEMENT

B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber

Synbiotic2

Intervention Type DIETARY_SUPPLEMENT

B. animalis subsp. lactis and prebiotics fiber

placebo +synbiotic2

Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Very low calorie ketogenic diet followed by low calorie diet

Synbiotic2

Intervention Type DIETARY_SUPPLEMENT

B. animalis subsp. lactis and prebiotics fiber

Interventions

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Diet

Very low calorie ketogenic diet followed by low calorie diet

Intervention Type OTHER

Synbiotic1

B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber

Intervention Type DIETARY_SUPPLEMENT

Synbiotic2

B. animalis subsp. lactis and prebiotics fiber

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* body mass index ≥ 30 kg/m2
* stable body weight in the previous 3 months

Exclusion Criteria

* Diabetes mellitus
* Obesity induced by endocrine disorders or by drugs
* Gastrointestinal disorders
* Use of antibiotics, probiotic or prebiotic agent which could modify microbiota in the previous 3 months
* Severe depression or any other psychiatric disease
* Abuse of narcotics or alcohol
* Severe hepatic insufficiency
* Any type of renal insufficiency or gout episodes
* Neoplasia
* Previous events of cardiovascular or cerebrovascular disease
* Renal lithiasis
* Uncontrolled hypertension and hydroelectrolytic alterations
* Females with child-bearing potential, who were pregnant, breast-feeding, intending to become pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes