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

Inflammation Clinical Trial

— Pronokal  

Official title:

Effects of Very-low Ketogenic Diet in Gut Microbiota and Its Restitution With the Use of Synbiotic Supplementation in Patients Following a Weight Loss Programme (Pronokal Method)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530501
• Other study ID #: JGA-BIOPNK-2016-01
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: March 13, 2018

Study information

• Verified date: April 2018
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Weight Loss

Intervention

Other:
• Diet
Very low calorie ketogenic diet followed by low calorie diet

Dietary Supplement:
• Synbiotic1
B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber
• Synbiotic2
B. animalis subsp. lactis and prebiotics fiber

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention	Fecal samples were collected at baseline and at the end of dietary intervention. Fecal DNA was extracted and Gut microbiota analysis was achieved by using high-throughput sequencing	At baseline and at 4 months
Secondary	Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention	Blood samples were collected at baseline and at the end of study. Plasma Zonulin levels were measured by enzyme linked immunosorbent assay	At baseline and at 4 months
Secondary	Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention	Blood samples were collected at baseline and at the end of study. Plasma C-reactive protein levels were measured by enzyme linked immunosorbent assay	At baseline and at 4 months
Secondary	Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention	Blood samples were collected at baseline and at the end of study. Plasma lipopolysaccharide binding protein levels were measured by enzyme linked immunosorbent assay	At baseline and at 4 months