Glycemic Evaluation of Okra Seed Noodles

NCT03990844 | Completed DMC

• 1 other identifier: 2018/00964
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Glucose; Insulin; Ghrelin; GLP-1

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 hour

Secondary Outcomes (3)

• Change in ghrelin level

  2 hour

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

  2 hour

• Change in satiety rating

  2 hour

Study Arms (3)

0% Okra seed noodle

PLACEBO COMPARATOR

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

10% Okra seed noodle

EXPERIMENTAL

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

Dietary Supplement: Okra seed

20% Okra seed noodle

EXPERIMENTAL

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

Dietary Supplement: Okra seed

Interventions

Okra seed DIETARY_SUPPLEMENT

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

0% Okra seed noodle; 10% Okra seed noodle; 20% Okra seed noodle

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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):
• unit = 12 oz or 360 mL of beer;
• oz or 150 mL of wine;
• 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:

Sponsors & Collaborators

• National University of Singapore: lead
• National University Health System: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore, 119077, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigators will randomized the subjects to consume the noodles at different enrichment levels. Subjects will not know the level of enrichment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: January 12, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 15, 2024

Record last verified: 2021-07

Locations

SG (1)