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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Very low calorie ketogenic diet followed by low calorie diet |
|
| Synbiotic1+synbiotic2 | Experimental | Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2 |
|
| placebo +synbiotic2 | Experimental | Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Very low calorie ketogenic diet followed by low calorie diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Manuel GarcÃa-Almeida, MD | Hospital Universitario Virgen de la Victoria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31298466 | Derived | 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. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D007249 | Inflammation |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Synbiotic1 | Dietary Supplement | B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber |
|
| Synbiotic2 | Dietary Supplement | B. animalis subsp. lactis and prebiotics fiber |
|
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 | 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 |
| D010335 | Pathologic Processes |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |