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Completed

NCT Number: NCT03530501

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

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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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

Very low calorie ketogenic diet followed by low calorie diet

Synbiotic1

Dietary Supplement

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

Synbiotic2

Dietary Supplement

B. animalis subsp. lactis and prebiotics fiber

Primary outcomes

  1. Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention

    Time frame: At baseline and at 4 months

    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

Secondary outcomes

  1. Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention

    Time frame: At baseline and at 4 months

    Blood samples were collected at baseline and at the end of study. Plasma Zonulin levels were measured by enzyme linked immunosorbent assay

  2. Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention

    Time frame: At baseline and at 4 months

    Blood samples were collected at baseline and at the end of study. Plasma C-reactive protein levels were measured by enzyme linked immunosorbent assay

  3. Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention

    Time frame: At baseline and at 4 months

    Blood samples were collected at baseline and at the end of study. Plasma lipopolysaccharide binding protein levels were measured by enzyme linked immunosorbent assay

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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)

Acronym: Pronokal

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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