Clinical trial NCT03530501: Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Inflammation
Keywords: microbiota
obesity
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention
timeFrame: At baseline and at 4 months
Secondary outcomes:
measure: Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention
timeFrame: At baseline and at 4 months
measure: Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention
timeFrame: At baseline and at 4 months
measure: Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention
timeFrame: At baseline and at 4 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Universitario Virgen de la Victoria
name: José Manuel García-Almeida, MD
role: STUDY_DIRECTOR
References:
citation: Gutierrez-Repiso C, Hernandez-Garcia C, Garcia-Almeida JM, Bellido D, Martin-Nunez GM, Sanchez-Alcoholado L, Alcaide-Torres J, Sajoux I, Tinahones FJ, Moreno-Indias I. Effect of Synbiotic Supplementation in a Very-Low-Calorie Ketogenic Diet on Weight Loss Achievement and Gut Microbiota: A Randomized Controlled Pilot Study. Mol Nutr Food Res. 2019 Oct;63(19):e1900167. doi: 10.1002/mnfr.201900167. Epub 2019 Aug 29.