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

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Completed

Conditions: Weight Loss; Inflammation

Treatments: Other: Diet; Dietary Supplement: Synbiotic2; Dietary Supplement: Synbiotic1

Study type: Interventional

Funder types: Other

Identifiers

NCT03530501

JGA-BIOPNK-2016-01

Details and patient eligibility

About

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

Full description

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).

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Very low calorie ketogenic diet followed by low calorie diet

Treatment:

Other: Diet

Synbiotic1+synbiotic2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Synbiotic1

Dietary Supplement: Synbiotic2

Other: Diet

placebo +synbiotic2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Synbiotic2

Other: Diet