Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Dietary Supplement: Okra seed | Not Applicable |
Research has confirmed that a food's glycemic effect cannot be accurately predicted from the type and amount of carbohydrates it contains, as the rate at which the carbohydrates is digested and released into the bloodstream is influenced by many factors such as the food's physical form, its fat, protein and fibre content, and the chemical structure of its carbohydrates. For these reasons, it is possible to produce food from the same group with different effects on blood glucose. Consumption of low glycemic index (GI) food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. However, there are few dietary intervention studies attempting to change the GI of food by changing the staple carbohydrates. In this study, the glycemic index of noodle fortified with Okra seed extract will be determined as compared to a control without the fortification. The fortified noodles have been previously tested to produce lower glycaemic response than noodle without fortification. With noodles being one of the staples to many Singaporeans, noodles fortified with functional ingredients derived from food sources offer a lower GI alternative to the conventional noodles without affecting the people dietary preference.
In the investigator's preliminary study, okra exhibits potential as an anti-diabetic food ingredient in the formulation of low GI staple foods. Indian okra was the most effective overall starch hydrolase inhibitor, inhibiting α-amylase with 50 percent inhibitory concentration (IC50) 2.94 + 0.70 μg/mL and α-glucosidase with IC50 of 23.98 + 1.88 μg/mL. Incorporation of okra seeds into tapioca starch, and rice flour noodles successfully lowered digestibility. To verify in vitro results, human clinical trials is proposed to investigate whether okra seed fortification in noodles successfully retards postprandial hyperglycaemia in humans when consumed.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | This study is a within-subject cross-over trial to assess the glycemic and insulinemic responses of 0%, 10% and 20% okra-seed enriched noodles in healthy human subjects. |
Masking: | Single (Participant) |
Masking Description: | The investigators will randomized the subjects to consume the noodles at different enrichment levels. Subjects will not know the level of enrichment. |
Primary Purpose: | Prevention |
Official Title: | Glycemic Index Evaluation of Noodles Using Functional Ingredients Derived From Food Sources |
Actual Study Start Date : | January 12, 2019 |
Estimated Primary Completion Date : | December 30, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Placebo Comparator: 0% Okra seed noodle
In this arm, subjects will consume noodles made with 0% okra seed. This serves as a control arm for the study.
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Dietary Supplement: Okra seed
Noodle enriched with 10% and 20% Okra seed flour.
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Experimental: 10% Okra seed noodle
In this arm, subjects will consume noodles made with 10% okra seed.
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Dietary Supplement: Okra seed
Noodle enriched with 10% and 20% Okra seed flour.
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Experimental: 20% Okra seed noodle
In this arm, subjects will consume noodles made with 10% okra seed.
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Dietary Supplement: Okra seed
Noodle enriched with 10% and 20% Okra seed flour.
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A visual analogue scale (VAS) will be presented to the participants at 0, min, 30 min, 60 min , 90 min and 120 min, to indicate how they feel in response to 4 given statements by marking an "X" on a 100-mm line.
At time T=15 min, palatability of the treatment was assessed by five characteristics, from bad (0 mm) to good (100 mm). These characteristics were visual appeal, smell, taste, texture, and overall pleasantness of the meal given. Scores were determined by measuring the distance (in mm) from the let starting point of the line to the intersection of the "X". Subjects did not discuss their ratings.The primary outcome was area under the curve (AUC) for responses on the VAS calculated using the trapezoidal rule.
Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study.
Exclusion Criteria:
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):
Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
Singapore | |
National University of Singapore | |
Singapore, Singapore, 119077 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 17, 2019 | ||||
First Posted Date ICMJE | June 19, 2019 | ||||
Last Update Posted Date | February 26, 2020 | ||||
Actual Study Start Date ICMJE | January 12, 2019 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Glycemic Evaluation of Okra Seed Noodles | ||||
Official Title ICMJE | Glycemic Index Evaluation of Noodles Using Functional Ingredients Derived From Food Sources | ||||
Brief Summary | In Singapore, the Ministry of Health has declared a "War on Diabetes" and major efforts will be made to develop and deploy programs to prevent diabetes. One of the cornerstones of diabetes management involves dietary modifications to reduce postprandial hyperglycaemia. However, implementation of a low GI diet is highly complex requiring the individual to choose foods from a long list which are primarily based on western consumption patterns. Many foods in the Asian diet, which largely consist of carbohydrates such as white rice, noodles and other flour-based products, are not represented. An alternative solution will require innovative ways to alter commonly available food products that will not only help reduce postprandial glycaemia but also preserve the sensory characteristics of the foods to create a new generation of food products both functional and palatable. | ||||
Detailed Description |
Research has confirmed that a food's glycemic effect cannot be accurately predicted from the type and amount of carbohydrates it contains, as the rate at which the carbohydrates is digested and released into the bloodstream is influenced by many factors such as the food's physical form, its fat, protein and fibre content, and the chemical structure of its carbohydrates. For these reasons, it is possible to produce food from the same group with different effects on blood glucose. Consumption of low glycemic index (GI) food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. However, there are few dietary intervention studies attempting to change the GI of food by changing the staple carbohydrates. In this study, the glycemic index of noodle fortified with Okra seed extract will be determined as compared to a control without the fortification. The fortified noodles have been previously tested to produce lower glycaemic response than noodle without fortification. With noodles being one of the staples to many Singaporeans, noodles fortified with functional ingredients derived from food sources offer a lower GI alternative to the conventional noodles without affecting the people dietary preference. In the investigator's preliminary study, okra exhibits potential as an anti-diabetic food ingredient in the formulation of low GI staple foods. Indian okra was the most effective overall starch hydrolase inhibitor, inhibiting α-amylase with 50 percent inhibitory concentration (IC50) 2.94 + 0.70 μg/mL and α-glucosidase with IC50 of 23.98 + 1.88 μg/mL. Incorporation of okra seeds into tapioca starch, and rice flour noodles successfully lowered digestibility. To verify in vitro results, human clinical trials is proposed to investigate whether okra seed fortification in noodles successfully retards postprandial hyperglycaemia in humans when consumed. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: This study is a within-subject cross-over trial to assess the glycemic and insulinemic responses of 0%, 10% and 20% okra-seed enriched noodles in healthy human subjects. Masking: Single (Participant)Masking Description: The investigators will randomized the subjects to consume the noodles at different enrichment levels. Subjects will not know the level of enrichment. Primary Purpose: Prevention
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE | Dietary Supplement: Okra seed
Noodle enriched with 10% and 20% Okra seed flour.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE |
25 | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study.
Exclusion Criteria:
Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Singapore | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03990844 | ||||
Other Study ID Numbers ICMJE | 2018/00964 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mei Hui Liu, National University, Singapore | ||||
Study Sponsor ICMJE | National University, Singapore | ||||
Collaborators ICMJE | National University Health System | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | National University, Singapore | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |