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Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.

Primary Purpose

Pre Diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Soluble corn fiber

maltodextrin

About this trial

This is an interventional other trial for Pre Diabetes

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy Chinese male subjects aged between 21 and 60 years
Either one of the three criteria:
Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose <5.0mmol/L

Exclusion Criteria:

Do smoke
Have any metabolic diseases (such as diabetes, hypertension etc)
Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
Have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
Consume fiber supplements or other supplements that is likely to interfere with study outcomes
Have any severe food allergy (e.g. anaphylaxis to peanuts)
Have any known allergies to any food components of the study protocol
Have active Tuberculosis (TB) or currently receiving treatment for TB
Have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Is enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
Partake in sports at the competitive and/or endurance levels
Intentionally restrict food intake
Have poor veins impeding venous access
Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws

Sites / Locations

Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Arm Label

Control beverage with glucose powder

Beverage with soluble corn fiber

Beverage with maltodextrin

Snack with soluble corn fiber

Snack with maltodextrin

Arm Description

Standard glucose beverage with 50 g of glucose powder

Beverage with soluble corn fiber (50 gram of total carbohydrate)

Beverage with maltodextrin (50 gram of total carbohydrate)

snack with soluble corn fiber (50 gram of total carbohydrate)

Snack with maltodextrin (50 gram of total carbohydrate)

Outcomes

Primary Outcome Measures

Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).

Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).

Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Secondary Outcome Measures

Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).

Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Full Information

NCT ID

NCT03279107

First Posted

September 6, 2017

Last Updated

August 19, 2021

Sponsor

JeyaKumar Henry

Collaborators

Tate and Lyle Ingredients France

1. Study Identification

Unique Protocol Identification Number

NCT03279107

Brief Title

Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.

Official Title

Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 25, 2017 (Actual)

Primary Completion Date

July 21, 2020 (Actual)

Study Completion Date

July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

JeyaKumar Henry

Collaborators

Tate and Lyle Ingredients France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.

Detailed Description

Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian phenotype has been shown to be most susceptible to diabetes than Caucasians. More importantly, the transition from prediabetes to diabetes is more drastic and severe in Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood glucose raising potential of carbohydrate foods. There is substantial evidence suggesting that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and help in the prevention and management of diabetes and prediabetes. Given the rising incidence of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological management of diabetes are increasingly being encouraged. The majority of studies on GI and Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown to have a greater GR to the same food compared to Caucasians. Simple dietary modification such as increasing dietary fiber in a food has been shown to reduce GR. However, it is unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect. Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if similar effects could be obtained when it is replaced with soluble fiber. Using the continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing glycemic excursions and reducing food intake in healthy Asian males. These simple dietary interventions appear to be an acceptable approach in improving overall glycemia and energy balance in Asians.

6. Conditions and Keywords

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

Pre Diabetes, Obesity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

randomized

Masking

Participant

Masking Description

Single Participant

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control beverage with glucose powder

Arm Type

No Intervention

Arm Description

Standard glucose beverage with 50 g of glucose powder

Arm Title

Beverage with soluble corn fiber

Arm Type

Experimental

Arm Description

Beverage with soluble corn fiber (50 gram of total carbohydrate)

Arm Title

Beverage with maltodextrin

Arm Type

Experimental

Arm Description

Beverage with maltodextrin (50 gram of total carbohydrate)

Arm Title

Snack with soluble corn fiber

Arm Type

Experimental

Arm Description

snack with soluble corn fiber (50 gram of total carbohydrate)

Arm Title

Snack with maltodextrin

Arm Type

Experimental

Arm Description

Snack with maltodextrin (50 gram of total carbohydrate)

Intervention Type

Other

Intervention Name(s)

Soluble corn fiber

Intervention Description

soluble corn fiber

Intervention Type

Other

Intervention Name(s)

maltodextrin

Intervention Description

maltodextrin

Primary Outcome Measure Information:

Title

Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).

Description

Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Time Frame

up to 180 minutes

Title

Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).

Description

Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Time Frame

up to 180 minutes

Secondary Outcome Measure Information:

Title

Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).

Description

Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

Time Frame

up to 180 minutes

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

healthy male

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Chinese male subjects aged between 21 and 60 years Either one of the three criteria: Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose <5.0mmol/L Exclusion Criteria: Do smoke Have any metabolic diseases (such as diabetes, hypertension etc) Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) Have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics) Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug Consume fiber supplements or other supplements that is likely to interfere with study outcomes Have any severe food allergy (e.g. anaphylaxis to peanuts) Have any known allergies to any food components of the study protocol Have active Tuberculosis (TB) or currently receiving treatment for TB Have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Is enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC. Partake in sports at the competitive and/or endurance levels Intentionally restrict food intake Have poor veins impeding venous access Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws

Facility Information:

Facility Name

Clinical Nutrition Research Centre

City

Singapore

ZIP/Postal Code

117599

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.

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