Abdominal ObesityCHOICENCT05882149
Single Strain Probiotic
A study testing Single strain probiotic in people with Abdominal Obesity, run by Rosa Sola at 1 site in Spain.
Trial summary
Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases, such as dyslipidemia, type 2 diabetes and the reduction of visceral fat mass, body weight and waist circumference. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Single strain probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2023to 1 Feb 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥ 18 years old.
- Established diagnosis of abdominal obesity: waist circumference (WC) ≥ 102 cm for men and ≥ 88 cm for women.
- Voluntary, written, signed, informed consent to participate in the study.
- Agreement to comply with the protocol and study restrictions.
- Females of child-bearing potential require to provide a negative urine pregnancy test.
Who cannot join
- WC < 102 cm for men, <88 cm for women, and >150 cm.
- BMI ≥ 40 kg/m2.
- Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
- Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease, dementia, pancreatic disease, history of cancer within past 5 years, anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject.
- Immunosuppression or ongoing therapy causing immunosuppression.
- Pharmacologically-treated (medication/supplements) dyslipidemia.
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- Subjects consuming antibiotics in the previous 1 month.
- Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
- Use of drugs or supplements to manage body weight or body fat in the last 3 months.
- Use of laxatives or fiber supplements in the past 4 weeks.
- History of chronic active inflammatory disorders.
- History of bariatric surgery.
- History of any chronic gastrointestinal disease (e.g. IBD).
- Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
- Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past 3 months or planned cessation of the use of these products during the trial.
- Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise).
- Weight change (increase or loss) of 3 kg during the past 3 months.
- Pregnant or planning pregnancy during the study or breastfeeding.
- Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
- Illicit drug users.
- Alcohol abusers.
- Known hypersensitivity to any ingredients in the active or placebo products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Single Strain Probiotic, Delivered in a Chewing Gum, on the Reduction of Anthropometric Adiposity Biomarkers and the Improvement of Glucose Homeostasis in Abdominally Obese Individuals.
Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases, such as dyslipidemia, type 2 diabetes and the reduction of visceral fat mass, body weight and waist circumference.
In previous studies, it was shown that capsule/powder probiotic or postbiotic supplementation containing a single strain probiotic, could reduce anthropometric parameters, including the visceral fat area, and contribute to type 2 diabetes management in subjects with abdominal obesity. Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks. Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR, pulse pressure, waist circumference, body weight and triglycerides.
Read more
These findings suggest that this specific single strain probiotic as a probiotic or postbiotic, could be a complementary strategy in the management of cardiometabolic disease risk factors.
Probiotics have mostly been studied incorporated in dairy food matrix. Other food matrices, such as chewing gum, have scarcely been exploited by the food industry. Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action. Furthermore, it has a high acceptance amongst adults and children and present few side effects.
No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals.
The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals.
The specific objectives:
- To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers (waist-hip-ratio, body weight, BMI, total fat mass, visceral fat index, free fat mass, lean body mass, conicity index, visceral adipose tissue and subcutaneous fat).
- To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis.
- To evaluate the efficacy of single strain probiotic in the management of serum lipid levels.
- To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure.
- To asses Quality of life after single strain probiotic supplementation.
- To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation.
- To identify changes in gastrointestinal health after single strain probiotic supplementation.
- To identify changes in the oral microbiome after single strain probiotic supplementation.
- To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation.
Read the detailed description
A total of 120 adult volunteers will be included in the intervention (60 in each arm of the intervention).
During the CHOICE study, there will be 6 visits in total. Of these visits, 3 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1, face-to- face); visits during the intervention (V2, V3 and V4 via telephone); final study visit (V5, face-to-face).
In visits V0, V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples. In visits V1 and V5 volunteers must bring saliva and faeces samples.
In order to measure the changes in visceral adipose tissue, up to five days prior to the visit V1 and approximately up to 3 days prior after the V5, volunteers must have a Nuclear Magnetic Resonance (NMR) for measuring visceral fat.
CHOICE Study
Visit 0 (V0, week -1): Recruitment and selection
- Information to the volunteer and signature of the informed consent.
- Revision of the inclusion/exclusion criteria.
- Elaboration of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry (waist circumference; hip; body weight and composition; height).
- Blood sample extraction.
- Delivery of the 3-day dietary record and the material for feaces and saliva sample recollection for V1.
- Schedule the first visit and instructions (fasting).
Visit 1 (V1, week 0): Basal visit
- NMR (±5 days V1).
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry (waist circumference; hip; body weight and composition).
- Blood sample extraction.
- Abdominal fat Ultrasound.
- Checking the 3-day dietary record.
- Checking the Three Factor Eating Questionnaire (TFEQ).
- Checking the Bing Eating Scale (BES).
- Checking the satiety scale (VAS) and gastrointestinal health information.
- Collection of feaces samples.
- Collection of saliva samples.
- Delivery of the 3-day dietary record and the material for saliva and feaces sample for V5.
- Schedule the next telephone visit and also the final visit and instructions (fasting).
Visit 2 (V2, week 3): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions.
Visit 3 (V3, week 6): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions.
Visit 4 (V4, week 9): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions (fasting).
Visit 5 (V2, week 12): Final visit
- NMR (±3 days before V5).
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Anthropometry (waist circumference; hip; body weight and composition)
- Checking the concomitant medication.
- Blood sample extraction.
- Abdominal fat Ultrasound.
- Checking the 3-day dietary record.
- Checking the TFEQ.
- Checking the BES.
- Record of adverse effects.
- Checking the treatment compliance
- Checking the satiety scale. (VAS)
- Collection of feaces samples.
- Collection of saliva samples.
- Conditions
- Abdominal Obesity
- Being tested
- Single strain probiotic, Placebo
- Keywords
- waist circumference, visceral fat, probiotic supplementation, chewing gum
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single strain probioticDietary supplement
Sugar-free chewing gum with single strain probiotic and zinc.
The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch).
PlaceboDietary supplement
Sugar-free chewing gum.
The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Sugar-free chewing gum with single strain probiotic and zinc. A daily dose of 2 chewing gums containing 1x10^10 Colony Forming Unit (CFU) for 12 weeks. Receives: Dietary Supplement: Single strain probiotic |
| Placebo | Placebo comparator | Sugar-free chewing gum for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference
Difference in waist circumference (cm) measured by an MRI transverse body scan in one axial slice 5 cm over L5 from week 0 to week 12
Measured: From week 0 to Week 12
Changes in intra-abdominal area
Differences in intra-abdominal area (cm2) measured by MRI (transverse body scan in one axial slice 5cm over L5) from week 0 to week 12
Measured: Week 0 to week 12
Secondary outcomes (37)
Change in hip circumference
Differences in hip circumference (cm) measured at the widest portion of the buttocks using a 150-cm anthropometric steel measuring tape from week 0 to week 12
Measured: From week 0 to Week 12
Change in waist-hip-ratio
Differences in waist-hip-ratio (cm) measured as waist circumference/hip circumference from week 0 to week 12
Measured: From week 0 to Week 12
Change in Body weight
Differences in body weight (kg) measured using a Tanita MC 780-MA; Tanita Corp., Barcelona, Spain, from week 0 to week 12
Measured: From week 0 to Week 12
Change in Body mass index
Differences in body mass index (kg/m2) calculated as weight (kg) divided to height (m2), from week 0 to week 12
Measured: From week 0 to Week 12
Change in Total fat mass
Differences in total fat mass (% kg) measured using a Tanita MC 780-MA; Tanita Corp., Barcelona, Spain, from week 0 to week 12
Measured: From week 0 to Week 12
Change in Free fat mass
Differences in free fat mass (%, kg) measured using a Tanita MC 780-MA; Tanita Corp., Barcelona, Spain, from week 0 to week 12
Measured: From week 0 to Week 12
Change in Lean body mass
Differences in Lean body mass (%, kg) measured using a Tanita MC 780-MA; Tanita Corp., Barcelona, Spain, from week 0 to week 12
Measured: From week 0 to Week 12
Change in Visceral fat index
Differences in visceral fat index obtained using a Tanita MC 780-MA; Tanita Corp., Barcelona, Spain, from week 0 to week 12
Measured: From week 0 to Week 12
Change in Conicity index
Differences in Conicity index calculated as waist circumference (cm)/0.109 x square root of weight (kg)/height (m) from week 0 to week 12
Measured: From week 0 to Week 12
Change in Visceral adipose tissue
Differences in Visceral adipose tissue (cm2) measured by MRI (transverse body scan in one axial slice 5cm over L5-S1) from week 0 to week 12
Measured: From week 0 to Week 12
Change in Subcutaneous fat
Differences in Subcutaneous fat (cm2) measured by MRI, transverse body scan in one axial slice 5cm over L5-S1 from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Fasting blood glucose
Differences in Fasting blood glucose (mmol/L) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Fasting insulin
Differences in Fasting insulin (IU/mL) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in HOMA index
Differences in HOMA index measured with the formula insulin x glucose/405 from week 0 to week 12
Measured: From week 0 to Week 12
Changes in glycosylated hemoglobin (HbA1c)
Differences in glycosylated hemoglobin (%) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Total cholesterol
Differences in Total cholesterol (mmol/L) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in HDLc
Differences in HDLc (mmol/L) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in LDLc
Differences in LDLc (mmol/L) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Total Triglycerides
Differences inTotal Triglycerides (mmol/L) measured by Standardized methods in an automated analyzer from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Systolic blood pressure
Differences in Systolic blood pressure (mmHg) measured by an automatic phygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain) measured twice after adult respite 2-5 min seated, with a 1-min interval in between from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Diastolic blood pressure
Differences in Diastolic blood pressure (mmHg) measured by an automatic hygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain) measured twice after adult respite 2-5 min seated, with a 1-min interval in between from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Pulse Pressure
Differences in Pulse pressure (mmHg), calculated as the difference between the upper and lower numbers of blood pressure, from week 0 to week 12
Measured: From week 0 to Week 12
Changes in Three Factor Eating Questionnaire (TFEQ; Spanish edition)
Differences in TFEQ score from week 0 to week 12. The minimum score is 0 and maximum score is 100, and higher score means a worse outcome.
Measured: From week 0 to Week 12
Changes in Bing Eating Scale (BES; Spanish edition)
Differences in BES score from week 0 to week 12. The minimum score is 0 and maximum score is 46, and higher score means a worse outcome.maximum score is 100, and higher score means a worse outcome.
Measured: From week 0 to Week 12
Changes in dietary intake
Differences in dietary intake assessed by a 3-day dietary record from week 0 to week 12
Measured: From week 0 to week 12
Changes in Satiety
Differences in satiety, assessed by a Visual Annual Scale (VAS), from week 0 to week 3, week 6, week 9 and week 12. The minimum score is -100 mm and maximum score is 100 mm, and higher score means a better outcome.
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in bowel habit
Differences in bowel habit, assessed by bristol scale, from week 0 to week 3, week 6, week 9 and week 12. In this scale there are 7 descriptive points, the minimum score is "severe constipation" and maximum score is "severe diarrhea". The better outcome is in the middle of the 7 descriptive points (points 3 and 4): "normal".
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in flatulences
Differences in the presence of flatulence (yes or not), from week 0 to week 3, week 6, week 9 and week 12
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in nausea
Differences in the presence of nausea (yes or not), from week 0 to week 3, week 6, week 9 and week 12
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in reflux
Differences in the presence of reflux (yes or not), from week 0 to week 3, week 6, week 9 and week 12
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in abdominal distension
Differences in the presence of abdominal distension (yes or not), from week 0 to week 3, week 6, week 9 and week 12
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in diarrhea
Differences in the presence of diarrhea (yes or not), from week 0 to week 3, week 6, week 9 and week 12
Measured: From week 0 to week 3, week 6, week 9 and week 12
Changes in gut microbiota
Differences in Phyla composition, assessed by metagenomics, from week 0 to week 12
Measured: From week 0 to week 12
Changes in oral microbiota
Differences in Phyla composition, assessed by metagenomics, from week 0 to week 12
Measured: From week 0 to week 12
Change in Visceral adipose tissue
Differences in Visceral adipose tissue (mm) measured by ultrasound (xipho-umbilical axis, 1-5 cm above navel) from week 0 to week 12
Measured: From week 0 to week 12
Change in Waist Circumference
Changes in waist circumference (cm) measured at the 2cm above the umbilicus using a 150-cm anthropometric steel measuring tape from week 0 to week 12.
Measured: Week 0 to week 12
Changes in Subcutaneous adipose tissue measured by Ultrasound
Changes in Subcutaneous adipose tissue (mm) measured by ultrasound (xipho-umbilical axis, 1-5 cm above navel) from week 0 to week 12
Measured: Week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start22 Jun 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies 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
- Model description
- Randomized, double-blind, parallel, placebo-controlled intervention study. The total duration of the intervention will be 12 weeks. The study will have two arms of intervention. The intervention product will be: sugar-free chewing gum with single strain probiotic and zinc. The Placebo product will be: sugar-free chewing gum. The placebo products and the intervention products will present the same format and appearance, in order to ensure the double-blind intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosa Sola
- Sponsor type
- University, hospital or other
- Collaborators
- Biopolis S.L., Chic-kles Gum, S.L.
- Responsible party
- Sponsor-investigator, Rosa Sola, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882149
- Sponsor's protocol ID
- 074/2023
- Acronym
- CHOICE
- Status last verified
- Mar 2026
- First submitted
- 19 May 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Ten Hoevel C, Besora-Moreno M, Queral J, Llaurado E, Valls RM, Sola R, Pedret A. Ultrasound and MRI abdominal fat distribution and its associations with metabolic conditions in adults with abdominal obesity. Diabetes Obes Metab. 2026 Mar;28(3):2061-2074. doi: 10.1111/dom.70390. Epub 2025 Dec 17.
PubMed 41403258
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Single Strain Probiotic, Delivered in a Chewing Gum, on the Reduction of Anthropometric Adiposity Biomarkers and the Improvement of Glucose Homeostasis in Abdominally Obese Individuals.
- ClinicalTrials.gov ID
- NCT05882149
- Acronym / sponsor ID
- CHOICE / 074/2023
- Conditions
- Abdominal Obesity
- Keywords
- waist circumference, visceral fat, probiotic supplementation, chewing gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Rosa SolaUniversity, hospital or other
- Collaborators
- Biopolis S.L., Chic-kles Gum, S.L.
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 31 May 2023 (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.
Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases, such as dyslipidemia, type 2 diabetes and the reduction of visceral fat mass, body weight and waist circumference.
In previous studies, it was shown that capsule/powder probiotic or postbiotic supplementation containing a single strain probiotic, could reduce anthropometric parameters, including the visceral fat area, and contribute to type 2 diabetes management in subjects with abdominal obesity. Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks. Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR, pulse pressure, waist circumference, body weight and triglycerides.
These findings suggest that this specific single strain probiotic as a probiotic or postbiotic, could be a complementary strategy in the management of cardiometabolic disease risk factors.
Probiotics have mostly been studied incorporated in dairy food matrix. Other food matrices, such as chewing gum, have scarcely been exploited by the food industry. Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action. Furthermore, it has a high acceptance amongst adults and children and present few side effects.
No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals.
The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals.
The specific objectives:
- To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers (waist-hip-ratio, body weight, BMI, total fat mass, visceral fat index, free fat mass, lean body mass, conicity index, visceral adipose tissue and subcutaneous fat).
- To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis.
- To evaluate the efficacy of single strain probiotic in the management of serum lipid levels.
- To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure.
- To asses Quality of life after single strain probiotic supplementation.
- To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation.
- To identify changes in gastrointestinal health after single strain probiotic supplementation.
- To identify changes in the oral microbiome after single strain probiotic supplementation.
- To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation.
Detailed description
A total of 120 adult volunteers will be included in the intervention (60 in each arm of the intervention).
During the CHOICE study, there will be 6 visits in total. Of these visits, 3 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1, face-to- face); visits during the intervention (V2, V3 and V4 via telephone); final study visit (V5, face-to-face).
In visits V0, V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples. In visits V1 and V5 volunteers must bring saliva and faeces samples.
In order to measure the changes in visceral adipose tissue, up to five days prior to the visit V1 and approximately up to 3 days prior after the V5, volunteers must have a Nuclear Magnetic Resonance (NMR) for measuring visceral fat.
CHOICE Study
Visit 0 (V0, week -1): Recruitment and selection
- Information to the volunteer and signature of the informed consent.
- Revision of the inclusion/exclusion criteria.
- Elaboration of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry (waist circumference; hip; body weight and composition; height).
- Blood sample extraction.
- Delivery of the 3-day dietary record and the material for feaces and saliva sample recollection for V1.
- Schedule the first visit and instructions (fasting).
Visit 1 (V1, week 0): Basal visit
- NMR (±5 days V1).
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry (waist circumference; hip; body weight and composition).
- Blood sample extraction.
- Abdominal fat Ultrasound.
- Checking the 3-day dietary record.
- Checking the Three Factor Eating Questionnaire (TFEQ).
- Checking the Bing Eating Scale (BES).
- Checking the satiety scale (VAS) and gastrointestinal health information.
- Collection of feaces samples.
- Collection of saliva samples.
- Delivery of the 3-day dietary record and the material for saliva and feaces sample for V5.
- Schedule the next telephone visit and also the final visit and instructions (fasting).
Visit 2 (V2, week 3): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions.
Visit 3 (V3, week 6): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions.
Visit 4 (V4, week 9): Follow-up during the intervention
- Checking the concomitant medication.
- Record adverse effects.
- Checking adherence to product consumption (treatment compliance)
- Checking the satiety scale.
- Checking the gastrointestinal health.
- Schedule the next visit and instructions (fasting).
Visit 5 (V2, week 12): Final visit
- NMR (±3 days before V5).
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Anthropometry (waist circumference; hip; body weight and composition)
- Checking the concomitant medication.
- Blood sample extraction.
- Abdominal fat Ultrasound.
- Checking the 3-day dietary record.
- Checking the TFEQ.
- Checking the BES.
- Record of adverse effects.
- Checking the treatment compliance
- Checking the satiety scale. (VAS)
- Collection of feaces samples.
- Collection of saliva samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel, placebo-controlled intervention study. The total duration of the intervention will be 12 weeks. The study will have two arms of intervention. The intervention product will be: sugar-free chewing gum with single strain probiotic and zinc. The Placebo product will be: sugar-free chewing gum. The placebo products and the intervention products will present the same format and appearance, in order to ensure the double-blind intervention
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Single strain probioticSugar-free chewing gum with single strain probiotic and zinc. A daily dose of 2 chewing gums containing 1x10^10 Colony Forming Unit (CFU) for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSugar-free chewing gum for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects ≥ 18 years old.
- Established diagnosis of abdominal obesity: waist circumference (WC) ≥ 102 cm for men and ≥ 88 cm for women.
- Voluntary, written, signed, informed consent to participate in the study.
- Agreement to comply with the protocol and study restrictions.
- Females of child-bearing potential require to provide a negative urine pregnancy test.
Key exclusion criteria (22 listed)
- WC < 102 cm for men, <88 cm for women, and >150 cm.
- BMI ≥ 40 kg/m2.
- Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
- Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease, dementia, pancreatic disease, history of cancer within past 5 years, anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject.
- Immunosuppression or ongoing therapy causing immunosuppression.
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 |
|---|---|---|
| Single strain probioticSugar-free chewing gum with single strain probiotic and zinc. The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch). | Dietary supplement | Probiotic |
| PlaceboSugar-free chewing gum. The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch). | Dietary supplement | Placebo |
Primary outcome
Change in waist circumference
Time frame: From week 0 to Week 12
Difference in waist circumference (cm) measured by an MRI transverse body scan in one axial slice 5 cm over L5 from week 0 to week 12
Changes in intra-abdominal area
Time frame: Week 0 to week 12
Differences in intra-abdominal area (cm2) measured by MRI (transverse body scan in one axial slice 5cm over L5) from week 0 to week 12
37 secondary outcomes
Change in hip circumference
Time frame: From week 0 to Week 12
Change in waist-hip-ratio
Time frame: From week 0 to Week 12
Change in Body weight
Time frame: From week 0 to Week 12
Change in Body mass index
Time frame: From week 0 to Week 12
Change in Total fat mass
Time frame: From week 0 to Week 12
Change in Free fat mass
Time frame: From week 0 to Week 12
Change in Lean body mass
Time frame: From week 0 to Week 12
Change in Visceral fat index
Time frame: From week 0 to Week 12
Change in Conicity index
Time frame: From week 0 to Week 12
Change in Visceral adipose tissue
Time frame: From week 0 to Week 12
Change in Subcutaneous fat
Time frame: From week 0 to Week 12
Changes in Fasting blood glucose
Time frame: From week 0 to Week 12
Changes in Fasting insulin
Time frame: From week 0 to Week 12
Changes in HOMA index
Time frame: From week 0 to Week 12
Changes in glycosylated hemoglobin (HbA1c)
Time frame: From week 0 to Week 12
Changes in Total cholesterol
Time frame: From week 0 to Week 12
Changes in HDLc
Time frame: From week 0 to Week 12
Changes in LDLc
Time frame: From week 0 to Week 12
Changes in Total Triglycerides
Time frame: From week 0 to Week 12
Changes in Systolic blood pressure
Time frame: From week 0 to Week 12
Changes in Diastolic blood pressure
Time frame: From week 0 to Week 12
Changes in Pulse Pressure
Time frame: From week 0 to Week 12
Changes in Three Factor Eating Questionnaire (TFEQ; Spanish edition)
Time frame: From week 0 to Week 12
Changes in Bing Eating Scale (BES; Spanish edition)
Time frame: From week 0 to Week 12
Changes in dietary intake
Time frame: From week 0 to week 12
Changes in Satiety
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in bowel habit
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in flatulences
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in nausea
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in reflux
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in abdominal distension
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in diarrhea
Time frame: From week 0 to week 3, week 6, week 9 and week 12
Changes in gut microbiota
Time frame: From week 0 to week 12
Changes in oral microbiota
Time frame: From week 0 to week 12
Change in Visceral adipose tissue
Time frame: From week 0 to week 12
Change in Waist Circumference
Time frame: Week 0 to week 12
Changes in Subcutaneous adipose tissue measured by Ultrasound
Time frame: Week 0 to week 12
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 24 Mar 2026.
- Derived from this study: PubMed 41403258Jimenez-Ten Hoevel C, Besora-Moreno M, Queral J, Llaurado E, Valls RM, Sola R, Pedret A. Ultrasound and MRI abdominal fat distribution and its associations with metabolic conditions in adults with abdominal obesity. Diabetes Obes Metab. 2026 Mar;28(3):2061-2074. doi: 10.1111/dom.70390. Epub 2025 Dec 17.
- Individual participant dataSharing planned: No
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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 Single strain probiotic in people with Abdominal Obesity, run by Rosa Sola 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 5 inclusion and 22 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 24 Mar 2026. 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?
Change in waist circumference (time frame: From week 0 to Week 12). 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?
On the ClinicalTrials.gov record for NCT05882149, which also lists 1 linked publication.
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 24 Mar 2026.