An interventional study of Okra seed in Diabetes Mellitus, Type 2, sponsored by National University of Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by National University of Singapore · Not applicable, Interventional, and Prevention
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
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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)
In this arm, subjects will consume noodles made with 0% okra seed. This serves as a control arm for the study.
Dietary Supplement: Okra seed
In this arm, subjects will consume noodles made with 10% okra seed.
Dietary Supplement: Okra seed
In this arm, subjects will consume noodles made with 10% okra seed.
Dietary Supplement: Okra seed
Noodle enriched with 10% and 20% Okra seed flour.
Change in glucose response
A mixed meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in glucose response will be measured by comparing incremental area under the curve (iAUC) after ingestion of noodles.
Time frame: 2 hour
Change in insulin response
A mixed meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in insulin response will be measured by comparing incremental area under the curve (iAUC) after ingestion of noodles.
Time frame: 2 hour
Change in ghrelin level
A mixed meal tolerance test will be done to collect blood samples for ghrelin analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in ghrelin level will be measured by comparing AUC after ingestion of noodles.
Time frame: 2 hour
Change in glucagon-like peptide 1 (GLP-1) level
A mixed meal tolerance test will be done to collect blood samples for GLP-1 analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in GLP-1 level will be measured by comparing AUC after ingestion of noodles.
Time frame: 2 hour
Change in satiety rating
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.
Time frame: 2 hour
Plan to share: Undecided — Will be decided on a later date.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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National University of Singapore