Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method) (Pronokal)
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Málaga, Spain, 29010
- Hospital Universitario Virgen de la Victoria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Very low calorie ketogenic diet followed by low calorie diet
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Very low calorie ketogenic diet followed by low calorie diet
|
|
Experimental: Synbiotic1+synbiotic2
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
|
Very low calorie ketogenic diet followed by low calorie diet
B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber
B. animalis subsp.
lactis and prebiotics fiber
|
|
Experimental: placebo +synbiotic2
Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
|
Very low calorie ketogenic diet followed by low calorie diet
B. animalis subsp.
lactis and prebiotics fiber
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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At baseline and at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At baseline and at 4 months
|
|
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
|
At baseline and at 4 months
|
|
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
|
At baseline and at 4 months
|
Collaborators and Investigators
Investigators
- Study Director: José Manuel García-Almeida, MD, Hospital Universitario Virgen de la Victoria
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JGA-BIOPNK-2016-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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