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De klinische studie NCT07089732 voor Obesitas, Prediabetes is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals 100 Dieet
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De klinische studie NCT07089732 is een interventioneel studie bij Obesitas, Prediabetes met de status nog niet rekruterend. De inclusie van 100 deelnemers start op 8 augustus 2025. De studie wordt geleid door Chung Shan Medical University en de voltooiing is gepland op 30 juni 2026. Laatste update op ClinicalTrials.gov: 28 juli 2025.
Beknopte samenvatting
A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.
Uitgebreide beschrijving
This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to thei...Toon meer
Officiële titel
Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations
Aandoeningen
ObesitasPrediabetesAndere studie-ID's
- CS2-24199
NCT-ID
Startdatum (Werkelijk)
2025-08-08
Laatste update geplaatst
2025-07-28
Verwachte einddatum
2026-06-30
Inschrijving (Geschat)
100
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Dubbelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelGLP-1 formula liquid drink GLP-1 formula liquid drink, 50 g/glass jar | GLP-1 formula liquid drink One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
Placebo-comparatorplacebo The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component. | PLACEBO One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Change from baseline in BMI at weeks 8 and 12 | Assessment of changes in BMI at baseline, week 8, and week 12 | Week 0, 8 and 12 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Change from baseline in blood glucose at weeks 8 and 12 | Assessment of blood glucose changes at weeks 0, 8, and 12 | Week 0, 8 and 12 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- Adults aged 18 to 70 years.
- Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
- Have not participated in similar clinical studies within the past three months.
- Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.
- Diagnosed with autoimmune diseases or cancer.
- Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
- History of gastrointestinal surgery.
- Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
- Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
- History of major psychiatric disorders.
- History of substance abuse or alcohol dependency.
Chung Shan Medical UniversityCentraal Contactpersoon
Contact: Chin-Lin Hsu Professor, 04-24730022 Ext. 12222, [email protected]
1 Studielocaties in 1 landen
South
Chung Shan Medical University, Taichung, South, 402 Recruiting, Taiwan
Chin-Lin Hsu Professor, Contact, 04-24730022 Ext. 12222, [email protected]