- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07597382
A Study of NatureU Burn on Satiety in Healthy Adults (NUBURN)
May 15, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
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Yongzhou, Hunan, China, 425300
- Dao County People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reference Food Session
Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.
|
The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.
|
|
Experimental: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2024
Primary Completion (Actual)
April 26, 2024
Study Completion (Actual)
May 5, 2024
Study Registration Dates
First Submitted
May 11, 2026
First Submitted That Met QC Criteria
May 15, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NATUREU-BURN-2024-SAT
- 2024041001 (Other Identifier: Dao County People's Hospital Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to privacy protection and ethical considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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