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临床试验/CTRI/2025/03/082283
CTRI/2025/03/082283尚未招募4 期

GLYCEMIC RESPONSE AND STORAGE STABILITY OF DEVELOPED FUNCTIONAL CANDIES FROM DRAGON FRUIT BY CO- PIGMENTING RHODODENDRON FLOWER ANTHOCYANIN EXTRACT

Shivi Tyagi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Glycemic Index (GI) of Best-Developed Candies

研究概览

简要总结

This study aims to investigate the glycemic response and storage stability of functional candies developed from dragon fruit co-pigmented with rhododendron flower anthocyanin extract. The trial will evaluate the glycemic index (GI) and glycemic load (GL) of the developed candies in healthy human participants. Additionally, the shelf life and sensory qualities of the candies will be assessed under different storage conditions. The study seeks to provide insights into the health benefits of these functional candies, focusing on their antioxidant properties and their potential impact on blood sugar regulation. Participants will consume the candies, and their blood glucose levels will be monitored to determine the glycemic response. The candies physicochemical and organoleptic properties will also be analyzed throughout the storage period to assess their stability and consumer acceptability.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
22.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Healthy Men and Women aged 22-25 years BMI between 18.5 to 23.5 Free from any treatments/medications Normal Blood Pressure Willing to participate No food allergies or intolerances.

排除标准

  • Individuals with a BMI outside the range of 18.5 to 23.5 kg/m².
  • Pregnant or lactating women.
  • Individuals with chronic medical conditions, particularly those affecting blood sugar levels (e.g., diabetes, hypoglycemia, or insulin resistance).
  • Individuals on medications that could affect glucose metabolism (e.g., steroids, oral contraceptives, etc.).
  • Individuals who are currently using dietary supplements (especially probiotics or any other supplements affecting blood glucose).
  • Individuals with uncontrolled blood pressure or cardiovascular disease.
  • Individuals with mental health conditions or any other condition that would make it impossible for them to understand or comply with the study protocol.
  • Individuals who have recently participated in another clinical trial or are likely to be involved in one during the study period.

结局指标

主要结局

Glycemic Index (GI) of Best-Developed Candies

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

Metric: GI calculated using Incremental Area Under the Curve (IAUC).

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

Glycemic Load (GL) of Best-Developed Candies

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

Time Point: 15, 30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

Metric: GL calculated using GI and carbohydrate content per serving.

时间窗: Glycemic Index (GI) of Best-Developed Candies | Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption | Metric: GI calculated using Incremental Area Under the Curve (IAUC). | Glycemic Load (GL) of Best-Developed Candies | Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days | Metric: GL calculated using GI and carbohydrate content per serving.

次要结局

  • Antioxidant Capacities, Sensory Characteristics, Microbial Stability, Colour Stability(0 DAY, 15 DAY, 30 DAY, 45 DAY, 60 DAY)

研究者

发起方
Shivi Tyagi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Neelam Chaturvedi

Banasthali Vidyapith

研究点 (1)

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