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| ID | Type | Description | Link |
|---|---|---|---|
| 2024041001 | Other Identifier | Dao County People's Hospital Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Food Session | Active Comparator | Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session. |
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| NatureU Burn Plus Glucose Session | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose Reference Food | Other | The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Law, Dr | OmniSolutions Laboratory Holdings Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dao County People's Hospital | Yongzhou | Hunan | 425300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
| Label | URL |
|---|---|
| Published article in Current Topics in Nutraceutical Research | View source |
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Individual participant data will not be shared due to privacy protection and ethical considerations.
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| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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Each participant completed two test sessions: one reference food session with glucose alone and one test food session with NatureU Burn plus glucose. The sessions were separated by at least 48 hours. The study used a non-randomized crossover design.
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The study was described as single-blind. Participants were masked. Investigator, care provider, and outcome assessor masking were not reported.
| NatureU Burn Plus Glucose | Dietary Supplement | 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. |
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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 |
| Food-Affected Desire for Food Score After NatureU Burn Plus Glucose Compared With Glucose Alone | 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 | 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 |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |