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The study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years.
Overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common.
The objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type I obesity (BMI 25 - 34.9 kg/m2).
This randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo).
In this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROBIOTIC | Experimental |
| |
| PLACEBO | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Food supplement based on probiotics in capsule format. Dose: 1 capsule/day. The active capsules contain probiotic strains at ≥1×10^9 cfu/dose and excipient. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight between baseline and 6- and 12-weeks | Baseline, 6-week and 12-week | |
| Changes in body mass index (BMI) baseline and 6- and 12-weeks | Baseline, 6-week and 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks | Baseline, 6-week and 12-week | |
| Changes in body composition between baseline and 12-weeks | Body composition is assessed by DEXA (Dual-Energy X-ray Absorptiometry). Lean mass and fat mass of the different body regions will be measured as grams (g) and percentage (%). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | AEs reported by participants, whether or not related to the intake of the investigational products, including required pharmacological treatments if applicable. | 6-week and 12-week |
| Adherence rate to the investigational product |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MiBioPath Research Group (UCAM) | Murcia | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Food supplement in capsule format. Dose: 1 capsule/day. The placebo capsules contain only excipient (probiotics are not included). |
|
| Baseline and 12-week |
| Changes in blood pressure between baseline and 6- and 12-weeks | Baseline, 6-week and 12-week |
| Changes in gut microbiota composition between baseline and 12-weeks | Alpha diversity, beta diversity and bacterial taxonomic composition of the gut microbiota will be assessed by sequencing the 16S rRNA gene of stool samples. | Baseline and 12-week |
| Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks | Questionnaire with 15 questions related to gastrointestinal discomfort during the last month. Each question is valued according to: None = 1; Insignificant = 2; Mild = 3; Moderate = 4; Quite strong = 5; Strong = 6; and Very strong = 7. The total score is calculated by adding the number of answers answered for the different degrees of discomfort (1-7), and is between 15 and 105 points. The higher the score, the worse the indication of gastrointestinal symptoms. | Baseline, 6-week and 12-week |
| Changes in the score of International Physical Activity Questionnaire (IPAQ) between baseline and 12-weeks | International Physical Activity Questionnaire (IPAQ) measures the time spent being physically active during the past 7 days. The type of activity is divided into: vigorous activity, moderate activity, walking, and no activity (sitting). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Rate Units) per minute and week. The reference Mets values are:
Depending on the number of Mets, physical activity is categorized as high, moderate, or low. | Baseline and 12-week |
| Changes in the MEDiterranean LIFEstyle index (MEDLIFE) questionnaire between baseline and 12-weeks | The MEDiterranean LIFEstyle index (MEDLIFE) consists of 28 questions categorized into three blocks: 1. Consumption of Mediterranean foods (15 questions); 2. Mediterranean dietary habits (7 questions); and 3. Physical activity, rest, social habits and coexistence (6 questions). Each question is scored with 0 or 1 point depending on whether or not it meets the established criteria, so the total score is between 0 and 28 points (the higher the score, the greater the adherence to the Mediterranean lifestyle). | Baseline and 12-week |
| Changes in the score of the Simplified Nutritional Appetite Questionnaire (SNAQ) between baseline and 12-weeks | Simplified Nutritional Appetite Questionnaire (SNAQ) The questionnaire consists of 4 questions. The results are scored on the following numerical scale: a 1, b 2, c 3, d 4, e 5. The sum of the scores for the individual items constitutes the SNAQ score. The total score ranges from 5 to 20 points. | Baseline and 12-week |
| Changes in blood count between baseline and 12-weeks | Values of complete blood count. | Baseline and 12-week |
| Changes in glucose levels between baseline and 12-weeks | Blood glucose values. | Baseline and 12-week |
| Changes in insulin levels between baseline and 12-weeks | Blood insulin values. | Baseline and 12-week |
| Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks | Blood glycosylated hemoglobin (HbA1c) values. | Baseline and 12-week |
| Changes in LDL and HDL, and total cholesterol levels between baseline and 12-weeks | Blood LDL and HDL, and total cholesterol values. | Baseline and 12-week |
| Changes in triglycerides levels between baseline and 12-weeks | Blood triglycerides values. | Baseline and 12-week |
| Changes in creatinine and urea levels between baseline and 12-weeks | Blood creatinine and urea values. | Baseline and 12-week |
| Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks | Blood AST/GOT and ALT/GPT values. | Baseline and 12-week |
| Changes in C-reactive protein levels between baseline and 12-weeks | Blood C-reactive protein values. | Baseline and 12-week |
| Changes in leptin levels between baseline and 12-weeks | Blood leptin values. | Baseline and 12-week |
Adherence is assessed through leftover capsules and days between visits.
| 6-week and 12-week |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |