NCT07758387Toborzás még nem indult
Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity
Randomized Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Functional Gummies With Polydextrose Versus Placebo for Weight Control in Adults With Overweight or Obesity
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 14.
Rövid összefoglaló (regiszter, angolul)
Overweight and obesity are common conditions that increase the risk of metabolic and cardiovascular diseases. Polydextrose is a type of dietary fiber that may help increase feelings of fullness by influencing natural hormones involved in appetite regulation. It may also improve postprandial glycemic responses and modulate the gut microbiota. However, evidence for its effectiveness in weight management remains limited. The purpose of this study is to evaluate the efficacy and safety of functional gummies containing polydextrose compared with placebo for weight management in adults with overweight or obesity. Participants will be randomly assigned to receive either polydextrose or placebo gummies for 24 weeks, together with standardized dietary and physical activity recommendations. The primary objective is to compare the percentage change in body weight over 24 weeks between participants receiving polydextrose gummies and those receiving placebo. The study will also evaluate appetite and satiety, body composition, waist circumference, metabolic parameters, quality of life, gastrointestinal symptoms, and the safety and tolerability of the study product. The study hypothesis is that daily intake of polydextrose gummies for 24 weeks will lead to a greater reduction in body weight than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 96 (tervezett)
- Első benyújtás
- 2026. aug. 6.
- Kezdés
- 2026. okt. 19.
- Elsődleges befejezés
- 2027. okt. 29.
- Fő szponzor
- Nutris We Care About You S.L.
- Betegségek
- Elhízás
- NCT-szám
- NCT07758387
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 96
- 2026. okt. 19. és az elsődleges befejezés (2027. okt. 29.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Currently taking or having taken in the last 3 months medicines that affect appetite or body weight (such as anorectic drugs, GLP-1 receptor agonists, chronic corticosteroids, antipsychotics, or fiber supplements).
Más betegség
- Uncontrolled thyroid disease [thyroid-stimulating hormone (TSH) outside the normal range] or recent changes in thyroid medication in the last 3 months.
- Significant gastrointestinal disease (such as severe irritable bowel syndrome, Crohn's disease, or ulcerative colitis).
- History of bariatric surgery.
- Advanced chronic kidney disease (stage IV-V).
- Current or recent eating disorder.
- Known allergy or intolerance to any ingredient of the study gummies.
- History of severe gastrointestinal problems with fermentable fibers.
Laborértékek
- Type 2 diabetes with glycated hemoglobin (HbA1c) greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections.
- Treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors for diabetes, heart failure, or chronic kidney disease.
Egyéb
- Liver cirrhosis.
- Following a very low-calorie diet (less than 800 kcal/day).
- Alcohol dependence or heavy alcohol use that, in the investigator's opinion, could affect the study.
- Planning to start or recently started a specific weight-loss diet different from the one recommended by the study endocrinology service.
- Pregnancy or breastfeeding.
- Women of childbearing potential who are trying to become pregnant or plan to become pregnant during the study.
Kiket keres a vizsgálat
- Adults aged 18 to 70 years.
- Body mass index (BMI) between 25 and 39.9 kg/m² (overweight or obesity class I-II).
- Stable body weight (no change greater than 3%) in the 3 months before joining the study.
- Usually eat at least 2 meals per day.
- Able and willing to follow the study procedures for 24 weeks, attend all scheduled visits, and complete the required records.
- Willing and able to sign the informed consent form.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital Universitario Principe de Asturias | Alcalá de Henares | Spanyolország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.