Human Absorption Study of Liposomal Glucosamine Supplements
Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Glucosamine Supplements
The objective of this study is to evaluate the effects of liposomal encapsulation using different ratios of gum arabic and lecithin on the bioavailability of a liquid glucosamine supplement in humans.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study is a single-center, self-controlled crossover human trial designed to evaluate the differences in blood concentration changes and bioavailability following a single oral dose of glucosamine supplements.
Healthy adult participants aged 18 years and older will be enrolled. Each participant will complete four study sessions, with a minimum washout period of 7 days between sessions. On each study day, venous blood samples will be collected prior to test product administration (0 minutes) to assess glucosamine levels, complete blood count, blood lipids, blood glucose, and liver and kidney function indicators.
After baseline blood collection, a standardized breakfast will be provided and consumed within 10 minutes, followed by administration of the test product. Venous blood samples will then be collected at 0.5, 1, 2, 4, 8, and 24 hours post-intake to measure glucosamine concentrations. Lunch will be provided after the 4-hour blood draw, and dinner will be provided after the 8-hour blood draw. Identical meals will be provided on four study sessions.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tong-Lin Wu
- Numéro de téléphone: +886 02-87977811
- E-mail: Tony.Wu@tci-bio.com
Sauvegarde des contacts de l'étude
- Nom: Ping Lin
- Numéro de téléphone: +886 02-87977811
- E-mail: candice.lin@tci-bio.com
Lieux d'étude
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Taipei, Taïwan, 114
- Recrutement
- TCI Co., Ltd
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Contact:
- Ping Lin
- Numéro de téléphone: +886 02-8797-7811
- E-mail: candice.lin@tci-bio.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged ≥18 years, regardless of sex, who are willing to sign the informed consent form and are able to fully comply with all study procedures.
Exclusion Criteria:
- Pregnant or breastfeeding women, or individuals who are unwilling to use a physical method of contraception during the study period, such as condoms or an intrauterine device.
- Employees of TCI Co., Ltd. and their family members.
- Individuals who have regularly taken any supplements or medications containing glucosamine or N-acetylglucosamine (N-acetyl-glucosamine) within 14 days prior to study initiation, defined as use for ≥7 consecutive days.
- Individuals with a history of chronic gastrointestinal disorders, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), chronic diarrhea, Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, or ulcerative colitis; a history of epilepsy or seizures; liver or kidney disease; malignancy; endocrine disorders; psychiatric disorders; alcohol or substance abuse; or other significant organic diseases, as determined based on medical history.
- Individuals with a history of gastrointestinal surgery, organ transplantation, or other major surgery.
- Individuals who have experienced acute gastroenteritis within 2 weeks prior to study initiation.
- Individuals with a history of allergy to any ingredient in the investigational products. The investigational products contain shrimp- and soy-derived ingredients.
- Vegetarians, as the glucosamine used in this study is derived from shrimp.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: High-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl, a high proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
Autres noms:
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Expérimental: Low-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl, a low proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
Autres noms:
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Comparateur actif: Glucosamine Liquid without Liposomal
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl and is not processed using the patented Double Nutri Liposomal technology. |
|
Comparateur actif: Glucosamine tablet without Liposomal
Three tablets will be administered per dose, with each tablet containing 500 mg of glucosamine. |
The tablet formulation primarily consists of glucosamine HCl and is not processed using liposomal technology. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma glucosamine level (ng/mL)
Délai: at 24 hours after taking test sample
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Plasma glucosamine levels will be measured at fasting and at 0.5, 1, 2, 4, 8, and 24 hours post-intake. |
at 24 hours after taking test sample
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tong-Lin Wu, TCI Co., Ltd.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-088-A
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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