A Study of NatureU Burn on Satiety in Healthy Adults (NUBURN)
15 mai 2026 mis à jour par: OmniSolutions Laboratory Holdings Limited
A Single-Center, Single-Blind, Non-Randomized Crossover Exploratory Study of NatureU Burn With Glucose on Postprandial Satiety in Healthy Adults
This single-center, single-blind, non-randomized crossover exploratory study evaluated the short-term effects of NatureU Burn on postprandial satiety in healthy adults.
NatureU Burn is an oral dietary supplement containing Irvingia gabonensis seed extract and high-molecular-weight inulin.
Fourteen healthy adults were enrolled, and 12 participants completed the study and were included in the effectiveness analysis.
Each participant completed two test sessions separated by at least 48 hours: a reference food session with 75 g medical anhydrous glucose in 250 mL warm purified water and a test food session with one capsule of NatureU Burn plus 75 g glucose in 250 mL warm purified water.
Satiety-related questionnaire scores were assessed at fasting baseline and at 30, 60, 90, 120, 180, and 240 minutes after the first bite in each session.
The study assessed fullness, hunger, desire for food, and prospective food consumption, and monitored adverse reactions.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This exploratory clinical study was conducted to assess whether NatureU Burn, when consumed with a glucose reference food, was associated with changes in satiety-related subjective indicators compared with glucose alone.
Eligible healthy adults completed screening, signed informed consent, and underwent two independent test sessions.
For 2 days before each test, participants were instructed to maintain regular routines and a normal diet.
On the day before testing, participants ate dinner between 18:00 and 20:00, avoided high-fiber and high-sugar foods, and fasted after 20:00.
On the test morning, participants avoided strenuous exercise, sat quietly for 10 minutes before testing, and completed a fasting satiety scale before taking the assigned food.
Participants consumed the assigned food and water within 5 to 10 minutes, and completed the satiety scale at 30, 60, 90, 120, 180, and 240 minutes after the first bite.
The four evaluated satiety indicators were fullness, hunger, desire for food, and prospective food consumption.
Food-affected changes were calculated relative to fasting baseline and compared between the NatureU Burn plus glucose session and the glucose reference session.
Safety monitoring included adverse reactions throughout the testing process.
Type d'étude
Interventionnel
Inscription (Réel)
14
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Hunan
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Yongzhou, Hunan, Chine, 425300
- Dao County People's Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Healthy adults aged 18 to 50 years.
- Male or female participants.
- Body mass index within the normal range of 18.5 to 23.9 kg/m2.
- Regular habit of eating breakfast.
- Able to fast for at least 10 hours after dinner.
- Signed informed consent before enrollment.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Individuals engaged in heavy physical labor or high-intensity exercise.
- Chronic sleep deprivation during the previous 3 months.
- Self-reported body weight increase or decrease of at least 4 kg during the previous 3 months.
- Current use of weight-loss medications.
- Special dietary patterns, such as low-carbohydrate diet or intermittent fasting.
- Abnormal eating attitude based on eating attitude assessment.
- Serious cardiovascular, hepatic, renal, gastrointestinal, hematologic, or neurologic dysfunction.
- History of bariatric surgery.
- Major surgery or hospitalization within the previous 3 months.
- Eating disorders, including binge eating disorder, anorexia nervosa, or bulimia nervosa.
- Abnormal glucose metabolism or lipid metabolism.
- Intolerance or allergy to the test foods.
- Excessive smoking, defined as more than 15 cigarettes per day.
- Alcohol consumption greater than 15 g alcohol per day.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Reference Food Session
Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.
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The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.
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Expérimental: NatureU Burn Plus Glucose Session
Participants consumed one capsule of NatureU Burn with 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the test food session.
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The test food consisted of one capsule of NatureU Burn plus 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.
NatureU Burn is an oral dietary supplement containing Irvingia gabonensis seed extract and high-molecular-weight inulin.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Délai: Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session.
|
Fullness was assessed using the satiety scale.
Food-affected fullness was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.
Fullness was assessed using the fullness item of the 100-point Satiety Rating Scale.
The scale ranges from 0 to 100, with higher scores indicating greater fullness and a better satiety outcome.
Food-affected fullness was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.
A larger positive change from baseline indicates a greater increase in fullness
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Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Délai: Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
|
Hunger was assessed using the satiety scale.
Food-affected hunger was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.Hunger was assessed using the hunger item of the 100-point Satiety Rating Scale.
The scale ranges from 0 to 100, with higher scores indicating greater hunger and a worse satiety outcome.
Food-affected hunger was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.
A larger negative change from baseline indicates a greater reduction in hunger.
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Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
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Food-Affected Desire for Food Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Délai: Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
|
Desire for food was assessed using the satiety scale.
Food-affected desire for food was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.Desire for food was assessed using the desire-for-food item of the 100-point Satiety Rating Scale.
The scale ranges from 0 to 100, with higher scores indicating greater desire for food and a worse satiety outcome.
Food-affected desire for food was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.
A larger negative change from baseline indicates a greater reduction in desire for food
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Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
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Food-Affected Prospective Food Consumption Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Délai: Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
|
Prospective food consumption was assessed using the satiety scale.
Food-affected prospective food consumption was calculated as the change from fasting baseline at each postprandial time point and compared between the NatureU Burn plus glucose test session and the glucose reference session.
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Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Luo L, Law L, Yu M, Zhang N, Yang M. Participant Experiences from Chronic Administration of Irvingia Gabonensis Seed Extract and Inulin on the Body's Satiety: An Exploratory Analysis of a Single-Blind Clinical Trial. Current Topics in Nutraceutical Research. 2025;23(1):56-63. doi:10.37290/ctnr2641-452X.22:56-63.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 avril 2024
Achèvement primaire (Réel)
26 avril 2024
Achèvement de l'étude (Réel)
5 mai 2024
Dates d'inscription aux études
Première soumission
11 mai 2026
Première soumission répondant aux critères de contrôle qualité
15 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NATUREU-BURN-2024-SAT
- 2024041001 (Autre identifiant: Dao County People's Hospital Ethics Committee)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared due to privacy protection and ethical considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .