Acute and Long-term Health Effects of Various Carbohydrates on Blood Glucose Management in Humans
NCT Number: NCT06554002
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition, Healthy
Interventions: OTHER: Control|OTHER: Treatment
Sponsor: Clinical Nutrition Research Centre, Singapore
Sex: ALL
Age: ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-08-14
Completion Date: 2023-08-14
Locations: Clinical Nutrition Research Centre (CNRC), Singapore, 117599, Singapore

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.

Primary Outcome Measures: 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 Outcome Measures: 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)., Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture., 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),, Energy expenditure measured in a whole room calorimeter (WRC)., 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., Subjective appetite sensations collected using validated 100mm visual analog scale questionnaires. Four questions on hunger, fullness, desire to eat, prospective consumption. Questions anchored at 0 mm being the "least" and at 100 mm being "most". For example, for prospective consumption " How much food do you think you can eat now?", at 0mm (nothing at all) to 100 mm (a large amount). Results captured electronically using the software AVAS (available at: http://www.nrlc-group.net/software/AdaptiveVisual.php)., 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).