NCT07597382

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4 days

First QC Date

May 11, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

NatureU BurnIrvingia gabonensis seed extracthigh-molecular-weight inulinsatietyprospective food consumptiondietary supplementNatureU

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Food-Affected Hunger Score After NatureU Burn Plus Glucose Compared With Glucose Alone

    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

    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

    Fasting baseline before food intake and 30, 60, 90, 120, 180, and 240 minutes after the first bite in each test session

Study Arms (2)

Reference Food Session

ACTIVE COMPARATOR

Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.

Other: Glucose Reference Food

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.

Dietary Supplement: NatureU Burn Plus Glucose

Interventions

The reference food consisted of 75 g medical anhydrous glucose dissolved in 250 mL warm purified water.

Reference Food Session
NatureU Burn Plus GlucoseDIETARY_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.

Also known as: NatureU Burn, Irvingia gabonensis seed extract and inulin supplement
NatureU Burn Plus Glucose Session

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dao County People's Hospital

Yongzhou, Hunan, 425300, China

Location

Related Publications (1)

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Lipid Metabolism DisordersObesityOverweight

Interventions

Glucose

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Luke Law, Dr

    OmniSolutions Laboratory Holdings Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study was described as single-blind. Participants were masked. Investigator, care provider, and outcome assessor masking were not reported.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 19, 2026

Study Start

April 22, 2024

Primary Completion

April 26, 2024

Study Completion

May 5, 2024

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations