A Single-Center, Single-Blind, Non-Randomized Crossover Exploratory Study of NatureU Burn With Glucose on Postprandial Satiety in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The study was described as single-blind. Participants were masked. Investigator, care provider, and outcome assessor masking were not reported.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •Regular habit of eating breakfast.
- •Able to fast for at least 10 hours after dinner.
- •Signed informed consent before enrollment.
排除标准
- •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.
研究组 & 干预措施
Reference Food Session
Participants consumed 75 g medical anhydrous glucose dissolved in 250 mL warm purified water during the reference food session.
干预措施: Glucose Reference Food (Other)
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.
干预措施: NatureU Burn Plus Glucose (Dietary Supplement)
结局指标
主要结局
Food-Affected Fullness Score After NatureU Burn Plus Glucose Compared With Glucose Alone
时间窗: 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
次要结局
- 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)