Overweight, Obesity Grade INCT06815926
Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight
A study testing Probiotic in people with Overweight, Obesity Grade I, run by Bioithas SL at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity Grade I
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2025to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥ 18 years.
- Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I).
- Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study.
- Signing of informed consent.
Who cannot join
- Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain.
- Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study.
- Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months.
- Treatment with antibiotics in the previous 4 weeks.
- Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks.
- Consumption of products containing probiotics in the previous 2 months.
- Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients.
- In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
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.
Read more
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.
- Conditions
- Overweight, Obesity Grade I
- Being tested
- Probiotic, Placebo
- Keywords
- probiotics, overweight, obesity, food supplement, gut microbiota
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
PlaceboDietary supplement
Food supplement in capsule format. Dose: 1 capsule/day.
The placebo capsules contain only excipient (probiotics are not included).
| Study group | Role | What they receive |
|---|---|---|
| PROBIOTIC | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| PLACEBO | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight between baseline and 6- and 12-weeks
Measured: Baseline, 6-week and 12-week
Changes in body mass index (BMI) baseline and 6- and 12-weeks
Measured: Baseline, 6-week and 12-week
Secondary outcomes (18)
Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks
Measured: 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 (%).
Measured: Baseline and 12-week
Changes in blood pressure between baseline and 6- and 12-weeks
Measured: 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.
Measured: 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.
Measured: 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:
- Walking: 3.3 Mets.
- Moderate physical activity: 4 Mets.
- Intense physical activity: 8 Mets. To obtain the total number of Mets, the reference Mets values are multiplied by the time in minutes of performing each type of activity in a day and by the number of days per week that it is performed.
Depending on the number of Mets, physical activity is categorized as high, moderate, or low.
Measured: 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).
Measured: 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.
Measured: Baseline and 12-week
Changes in blood count between baseline and 12-weeks
Values of complete blood count.
Measured: Baseline and 12-week
Changes in glucose levels between baseline and 12-weeks
Blood glucose values.
Measured: Baseline and 12-week
Changes in insulin levels between baseline and 12-weeks
Blood insulin values.
Measured: Baseline and 12-week
Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks
Blood glycosylated hemoglobin (HbA1c) values.
Measured: 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.
Measured: Baseline and 12-week
Changes in triglycerides levels between baseline and 12-weeks
Blood triglycerides values.
Measured: Baseline and 12-week
Changes in creatinine and urea levels between baseline and 12-weeks
Blood creatinine and urea values.
Measured: Baseline and 12-week
Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks
Blood AST/GOT and ALT/GPT values.
Measured: Baseline and 12-week
Changes in C-reactive protein levels between baseline and 12-weeks
Blood C-reactive protein values.
Measured: Baseline and 12-week
Changes in leptin levels between baseline and 12-weeks
Blood leptin values.
Measured: Baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start12 Feb 2025
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, Obesity Grade IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815926
- Sponsor's protocol ID
- Probi.Obes
- Status last verified
- Jul 2025
- First submitted
- 4 Feb 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
- ClinicalTrials.gov ID
- NCT06815926
- Acronym / sponsor ID
- Probi.Obes
- Conditions
- Overweight, Obesity Grade I
- Keywords
- probiotics, overweight, obesity, food supplement, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROBIOTIC | Experimental | Dietary Supplement: Probiotic |
| PLACEBO | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged ≥ 18 years.
- Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I).
- Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study.
- Signing of informed consent.
Key exclusion criteria (8 listed)
- Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain.
- Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study.
- Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months.
- Treatment with antibiotics in the previous 4 weeks.
- Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticFood 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. | Dietary supplement | PROBIOTIC |
| PlaceboFood supplement in capsule format. Dose: 1 capsule/day. The placebo capsules contain only excipient (probiotics are not included). | Dietary supplement | PLACEBO |
Primary outcome
Changes in body weight between baseline and 6- and 12-weeks
Time frame: Baseline, 6-week and 12-week
Changes in body mass index (BMI) baseline and 6- and 12-weeks
Time frame: Baseline, 6-week and 12-week
18 secondary outcomes
Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks
Time frame: Baseline, 6-week and 12-week
Changes in body composition between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in blood pressure between baseline and 6- and 12-weeks
Time frame: Baseline, 6-week and 12-week
Changes in gut microbiota composition between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks
Time frame: Baseline, 6-week and 12-week
Changes in the score of International Physical Activity Questionnaire (IPAQ) between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in the MEDiterranean LIFEstyle index (MEDLIFE) questionnaire between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in the score of the Simplified Nutritional Appetite Questionnaire (SNAQ) between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in blood count between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in glucose levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in insulin levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in LDL and HDL, and total cholesterol levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in triglycerides levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in creatinine and urea levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in C-reactive protein levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Changes in leptin levels between baseline and 12-weeks
Time frame: Baseline and 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Overweight, Obesity Grade I, run by Bioithas SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight between baseline and 6- and 12-weeks (time frame: Baseline, 6-week and 12-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.