Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method) (Pronokal)
Primary Purpose
Weight Loss, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diet
Synbiotic1
Synbiotic2
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring microbiota, obesity
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
Sites / Locations
- Hospital Universitario Virgen de la Victoria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Synbiotic1+synbiotic2
placebo +synbiotic2
Arm Description
Very low calorie ketogenic diet followed by low calorie diet
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03530501
First Posted
April 5, 2018
Last Updated
May 18, 2018
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
1. Study Identification
Unique Protocol Identification Number
NCT03530501
Brief Title
Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Inflammation
Keywords
microbiota, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Very low calorie ketogenic diet followed by low calorie diet
Arm Title
Synbiotic1+synbiotic2
Arm Type
Experimental
Arm Description
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
Arm Title
placebo +synbiotic2
Arm Type
Experimental
Arm Description
Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Very low calorie ketogenic diet followed by low calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic1
Intervention Description
B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic2
Intervention Description
B. animalis subsp. lactis and prebiotics fiber
Primary Outcome Measure Information:
Title
Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention
Description
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
Time Frame
At baseline and at 4 months
Secondary Outcome Measure Information:
Title
Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention
Description
Blood samples were collected at baseline and at the end of study. Plasma Zonulin levels were measured by enzyme linked immunosorbent assay
Time Frame
At baseline and at 4 months
Title
Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention
Description
Blood samples were collected at baseline and at the end of study. Plasma C-reactive protein levels were measured by enzyme linked immunosorbent assay
Time Frame
At baseline and at 4 months
Title
Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention
Description
Blood samples were collected at baseline and at the end of study. Plasma lipopolysaccharide binding protein levels were measured by enzyme linked immunosorbent assay
Time Frame
At baseline and at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel García-Almeida, MD
Organizational Affiliation
Hospital Universitario Virgen de la Victoria
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31298466
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.
Results Reference
derived
Learn more about this trial
Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)
We'll reach out to this number within 24 hrs