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A Study of NatureU Burn on Satiety in Healthy Adults (NUBURN)

15 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

14

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Hunan
      • Yongzhou, Hunan, Cina, 425300
        • Dao County People's Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Reference Food Session
Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.
Altro: Glucose Reference Food
The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.
Sperimentale: 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.
Integratore alimentare: NatureU Burn Plus Glucose
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.
Altri nomi:
  • NatureU Burn
  • Irvingia gabonensis seed extract and inulin supplement

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Lasso di tempo: 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
Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Lasso di tempo: 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.
Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
Food-Affected Desire for Food Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Lasso di tempo: 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
Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session
Food-Affected Prospective Food Consumption Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Lasso di tempo: 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.
Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

OmniSolutions Laboratory Holdings Limited

Investigatori

  • Direttore dello studio: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 aprile 2024

Completamento primario (Effettivo)

26 aprile 2024

Completamento dello studio (Effettivo)

5 maggio 2024

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NATUREU-BURN-2024-SAT
  • 2024041001 (Altro identificatore: Dao County People's Hospital Ethics Committee)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to privacy protection and ethical considerations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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