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临床试验/NCT07371949
NCT07371949已完成不适用

APLIKASI CHRONO- NUTRITION : PENGARUH FIBER JELLY TERHADAP RESPON GLUKOSA DARAH, KEKENYANGAN POST PRANDIAL, DAN WEIGH LOSS PADA WANITA OVERWEIGHT"

Surabaya State University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年6月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Blood Glucose level

研究概览

简要总结

The goal of this observational study is to learn about the effects of pre meal fiber jelly in overweight women over the age of 20-60 who take intervention pre meal fiber jelly on their postprandial blood glucose level and appetite level.

The main question it aims to answer is:

Does pre meal fiber jelly in overweight women effect on their postprandial blood glucose level and appetite level?

详细描述

Prior to the test days, participants were asked to fast overnight following the standard procedure for fasting blood glucose measurement. Additionally, participants were asked to refrain from vigorous physical activity prior to the test days. On the test days, fasting blood glucose was taken prior to the breakfast test meal at 0 minute. Then, participants were asked to consume fibre jelly for those in the intervention group and carrageenan-based jelly for those in the control group. After consuming jelly, participants from both groups were asked to consume bread, which was equal to 50 grams of starch and 250 ml of water in 10 minutes. To measure their postprandial blood glucose levels, participants were required to fast for the next 2 hours. After blood samples were collected, participants were provided with a complete meal and unlimited water. Participants were allowed to eat and drink as much as they desire following their satiety and hunger cues (ad-libitum). The remaining foods were weighed to calculate the total calories consumed by participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) female adults aged between 20-60 years; (2) having fasting blood glucose level <125 mg/dL; (3) having body mass index (BMI) more than or equal to 23; (4) not undergoing loss weight program during the recruitment process; (5) not allergic to rosella and basil seed

排除标准

  • Candidates were excluded if they were pregnant or lactating, had any medical conditions, including gastrointestinal disorders, cardiovascular disease, or other chronic diseases, smoking, or consuming alcohol.

研究组 & 干预措施

Intervention

Active Comparator

Fibre jelly was formulated using basil seeds, psyllium husk, rosella water extract, and carrageenan. Fibre jelly contained approximately 7.89 g of fibre in each pouch (~100 g).

干预措施: Fiber jelly (Combination Product)

Placebo

Placebo Comparator

the control jelly was formulated using water and carrageenan as a gelling agent. Both types of jelly contained the same amount of stevia and fructose as sweeteners.

干预措施: Fiber jelly (Combination Product)

结局指标

主要结局

Blood Glucose level

时间窗: 0, 30, 45, 60, 90, 120 minute

Post prandial blood glucose level

Appetite level

时间窗: 0 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute, 180 minute, 240 minute

Visual analog scale of hunger, fullness, appetite, prospective food, and satisfaction

次要结局

未报告次要终点

研究者

发起方
Surabaya State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Noor Rohmah Mayasari

Assistant Professor

Surabaya State University

研究点 (1)

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