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

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ClinicalTrials.gov Identifier: NCT03279107
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Tate and Lyle Ingredients France
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Obesity Other: Soluble corn fiber Other: maltodextrin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized
Masking: Single (Participant)
Masking Description: Single Participant
Primary Purpose: Other
Official Title: Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
No Intervention: Control beverage with glucose powder
Standard glucose beverage with 50 g of glucose powder
Experimental: Beverage with soluble corn fiber
Beverage with soluble corn fiber (50 gram of total carbohydrate)
Other: Soluble corn fiber
soluble corn fiber

Experimental: Beverage with maltodextrin
Beverage with maltodextrin (50 gram of total carbohydrate)
Other: maltodextrin
maltodextrin

Experimental: Snack with soluble corn fiber
snack with soluble corn fiber (50 gram of total carbohydrate)
Other: Soluble corn fiber
soluble corn fiber

Experimental: Snack with maltodextrin
Snack with maltodextrin (50 gram of total carbohydrate)
Other: maltodextrin
maltodextrin




Primary Outcome Measures :
  1. Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes). [ Time Frame: up to 180 minutes ]
    Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

  2. Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes). [ 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 :
  1. Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes). [ Time Frame: up to 180 minutes ]
    Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   healthy male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279107


Contacts
Contact: JeyaKumar Christiani Henry, Phd 6407 0793 jeya_henry@sics.a-star.edu.sg
Contact: Kimberly Tan, Bsc 6407 4367 kimberly_tan@sics.a-star.edu.sg

Locations
Singapore
Clinical Nutrition Research Centre Recruiting
Singapore, Singapore, 117599
Contact: Kimberly Tan, Bsc       kimberly_tan@sics.a-star.edu.sg   
Contact: Winnie Chia, Bsc       chia_pei_fen@sics.a-star.edu.sg   
Sponsors and Collaborators
JeyaKumar Henry
Tate and Lyle Ingredients France

Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03279107     History of Changes
Other Study ID Numbers: 2017/00428
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia