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Glycemic Evaluation of Okra Seed Noodles

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Okra seed

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Glucose, Insulin, Ghrelin, GLP-1

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Ability to give informed consent
Chinese male/female age between 21-65 years old
Healthy as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
Not on any regular medications (western / traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable.

However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study.

Have venous access sufficient to allow for blood sampling as per the protocol
Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Body mass index of 18 to 25 kg/m2 (male) or 18 to 23 kg/m2 (female).

Exclusion Criteria:

History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
Known or ongoing psychiatric disorders within 3 years
Regularly use known drugs of abuse within 3 years
Women who are pregnant or lactating
Have donated blood of more than 500 mL within 4 weeks of study enrolment
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):
- 1 unit = 12 oz or 360 mL of beer;
- 5 oz or 150 mL of wine;
- 1.5 oz or 45 mL of distilled spirits
Uncontrolled hypertension (blood pressure >160/100mmHg)
Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
Known allergy to insulin
History of bleeding diathesis or coagulopathy
Any of the following laboratory values at screening:

Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)

Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity
Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
Significant change in weight (+/- 5%) during the past month
Known allergy to test food or ingredients used in preparation of test food.
Subjects with electrical implants/devices such as pacemaker.

Sites / Locations

National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

0% Okra seed noodle

10% Okra seed noodle

20% Okra seed noodle

Arm Description

In this arm, subjects will consume noodles made with 0% okra seed. This serves as a control arm for the study.

In this arm, subjects will consume noodles made with 10% okra seed.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03990844

First Posted

June 17, 2019

Last Updated

July 23, 2021

Sponsor

National University of Singapore

Collaborators

National University Health System

1. Study Identification

Unique Protocol Identification Number

NCT03990844

Brief Title

Glycemic Evaluation of Okra Seed Noodles

Official Title

Glycemic Index Evaluation of Noodles Using Functional Ingredients Derived From Food Sources

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

January 12, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

Collaborators

National University Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Glucose, Insulin, Ghrelin, GLP-1

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

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.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0% Okra seed noodle

Arm Type

Placebo Comparator

Arm Description

In this arm, subjects will consume noodles made with 0% okra seed. This serves as a control arm for the study.

Arm Title

10% Okra seed noodle

Arm Type

Experimental

Arm Description

In this arm, subjects will consume noodles made with 10% okra seed.

Arm Title

20% Okra seed noodle

Arm Type

Experimental

Arm Description

In this arm, subjects will consume noodles made with 10% okra seed.

Intervention Type

Dietary Supplement

Intervention Name(s)

Okra seed

Intervention Description

Noodle enriched with 10% and 20% Okra seed flour.

Primary Outcome Measure Information:

Title

Change in glucose response

Description

Time Frame

2 hour

Title

Change in insulin response

Description

Time Frame

2 hour

Secondary Outcome Measure Information:

Title

Change in ghrelin level

Description

Time Frame

2 hour

Title

Change in glucagon-like peptide 1 (GLP-1) level

Description

Time Frame

2 hour

Title

Change in satiety rating

Description

Time Frame

2 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to give informed consent Chinese male/female age between 21-65 years old Healthy as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data. Not on any regular medications (western / traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable. However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study. Have venous access sufficient to allow for blood sampling as per the protocol Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Body mass index of 18 to 25 kg/m2 (male) or 18 to 23 kg/m2 (female). Exclusion Criteria: History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data Known or ongoing psychiatric disorders within 3 years Regularly use known drugs of abuse within 3 years Women who are pregnant or lactating Have donated blood of more than 500 mL within 4 weeks of study enrolment Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females): 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits Uncontrolled hypertension (blood pressure >160/100mmHg) Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1 Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study Known allergy to insulin History of bleeding diathesis or coagulopathy Any of the following laboratory values at screening: Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L) Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study Significant change in weight (+/- 5%) during the past month Known allergy to test food or ingredients used in preparation of test food. Subjects with electrical implants/devices such as pacemaker.

Facility Information:

Facility Name

National University of Singapore

City

Singapore

ZIP/Postal Code

119077

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Will be decided on a later date.

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Glycemic Evaluation of Okra Seed Noodles

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