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

15. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Reference Food Session
Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.
Andet: Glucose Reference Food
The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.
Eksperimentel: 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.
Kosttilskud: 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.
Andre navne:
  • NatureU Burn
  • Irvingia gabonensis seed extract and inulin supplement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

OmniSolutions Laboratory Holdings Limited

Efterforskere

  • Studieleder: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. april 2024

Primær færdiggørelse (Faktiske)

26. april 2024

Studieafslutning (Faktiske)

5. maj 2024

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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