NCT05882149Befejeződött
Single Strain Probiotic
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.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 24.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 124 (tényleges)
- Első benyújtás
- 2023. máj. 19.
- Kezdés
- 2023. jún. 22.
- Elsődleges befejezés
- 2025. febr. 1.
- Fő szponzor
- Rosa Sola
- Betegségek
- Elhízás
- NCT-szám
- NCT05882149
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 124
- 2023. jún. 22. és az elsődleges befejezés (2025. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Immunosuppression or ongoing therapy causing immunosuppression.
- Pharmacologically-treated (medication/supplements) dyslipidemia.
- 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.
- Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
- Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
- Illicit drug users.
Más betegség
- 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.
- History of chronic active inflammatory disorders.
- History of bariatric surgery.
- History of any chronic gastrointestinal disease (e.g. IBD).
- Known hypersensitivity to any ingredients in the active or placebo products.
Laborértékek
- Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
Egyéb
- WC < 102 cm for men, <88 cm for women, and >150 cm.
- BMI ≥ 40 kg/m2.
- Use of laxatives or fiber supplements in the past 4 weeks.
- 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.
- Alcohol abusers.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Universitat Rovira i Virgili | Reus | Spanyolország | Ismeretlen állapot |
Kapcsolódó publikációk
- Ultrasound and MRI abdominal fat distribution and its associations with metabolic conditions in adults with abdominal obesity.Diabetes Obes Metab · 2026 · PMID 41403258
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