Acute and Long-term Health Effects of Various Carbohydrates on Blood Glucose Management in Humans

NCT06554002 | Completed

• 1 other identifier: 2017/00558
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary fibre, especially soluble fibre, has several health benefits such as lowering the risks for cardiovascular disease, stroke, diabetes, obesity, and gastrointestinal diseases. Resistant dextrin is a non-viscous soluble fibre, can be introduced quite easily in foods or as drinks, and it is well tolerated. This study aims to investigate if daily supplementation of habitual diets with resistant dextrin over 8 weeks affect glycaemic control via insulin sensitivity, intestinal fermentation, energy expenditure and fat oxidation in adults with increased risk for type 2 diabetes. The primary outcome is the effect on glycaemic control (fasting glucose, insulin, insulin sensitivity and 24 hour glycaemic response from CGMS). The secondary outcomes are the effects on fasting lipids, energy expenditure and fuel utilization in a whole room calorimeter and appetite regulation.

Conditions

Nutrition, Healthy

Keywords

resistant dextrin; glycaemic control; insulin sensitivity

Outcome Measures

Primary Outcomes (4)

• Glucose will be measured from fasting blood samples that will be collected at baseline (0 week), follow up visit (at 4 weeks) and at the end of the intervention (at 8 weeks).

  Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.

  Mid intervention visit on Week 4

• Insulin will be measured from fasting blood samples that will be collected at baseline (0 week), follow up visit (at 4 weeks) and at the end of the intervention (at 8 weeks).

  Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.

  Mid intervention visit on Week 4

• Insulin sensitivity will be measured from fasting blood samples that will be collected at baseline and final visit.

  Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.

  Mid intervention visit on Week 4

• 24 hour glycaemic response will measured in all participants during the baseline and at the end of the intervention (at 8 weeks).

  On Day 1 of the baseline and final test visits, participants will come to the laboratory in the evening (1600h) for continuous glucose monitoring system, CGMS (IPro®2, Medtronic, USA) insertion.

  Inserted on the Baseline visit (0 week) (Days 1-3) and Final visit (8 week) (Days 1-3)

Secondary Outcomes (3)

• Lipids will be measured measured from fasting blood samples that will be collected at baseline (0 week), follow up visit (at 4 weeks) and at the end of the intervention (at 8 weeks).

  Mid intervention visit on Week 4

• In a subset of 10 participants per study arm, energy expenditure will be measured in a whole room calorimeter on the baseline visit (0 week) and final visit (8 week),

  On Day 2 of baseline visit (0 week) for 9 hours

• Subjective appetite sensations collected before breakfast and lunch, and 4 hours postprandially at every half an hour, using validated 100mm visual analog scale questionnaires.

  Before breakfast and lunch, and 4 hours postprandial breakfast and lunch, obtained every half an hour. VAS conducted on Day 2 of baseline (0 week) and final visit (8 week).

Study Arms (2)

Control

EXPERIMENTAL

Flavoured beverage powder with 3g glucose, twice a day

Other: Control

Treatment

EXPERIMENTAL

Flavoured beverage powder with 20g resistant dextrin, twice a day

Other: Treatment

Interventions

Control OTHER

Participants will be asked to consume glucose on a daily basis (twice per day) for the entire 8 weeks. The supplement will be packed in sachets, and it can be dissolved in water to be consumed as a beverage. Two sachets will be consumed daily.

Control

Treatment OTHER

Participants will be asked to consume a resistant dextrin on a daily basis (twice per day) for the entire 8 weeks. The test supplement will be packed in sachets, and it can be dissolved in water to be consumed as a beverage. Two sachets will be consumed daily.

Treatment

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old
• Group A: 21 - 25 kg/m2, with first degree family history of type 2 diabetes, or Group B: 23 - 30 kg/m2, with waist circumference \>85 cm for males and \>82 cm for females

You may not qualify if:

• Consume fibre supplements or any other supplements that is likely to interfere with study outcomes
• 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
• Smoking
• Have any metabolic diseases (e.g. diabetes, hypertension)
• Have medical conditions and/or taking medications known to affect glycaemia (e.g. glucocorticoids, thyroid hormones, thiazide diuretics)
• Have glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Have any severe food allergy (e.g. anaphylaxis to peanuts), or any other known food allergy/intolerance
• 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)
• A team member of the study or their immediate family members (i.e. spouse, parent, child, or sibling, whether biological or legally adopted)
• Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
• Intentionally restricting food intake
• Have poor veins impeding venous access
• Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
• Have claustrophobia

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre (CNRC)

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single-blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Crossover assignment. Single-blinded, randomized, controlled, parallel arm trial with each participant block-randomized into either control or treatment group

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 14, 2024
• Study Start: August 14, 2019
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

SG (1)