Nutrition, HealthyNCT06554002
Acute and Long-term Health Effects of Various Carbohydrates on Blood Glucose Management in Humans
A study testing Treatment in people with Nutrition, Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Aug 2019to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21 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
Who cannot join
- • 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute-postprandial and Long-term Effects of Different Types of Carbohydrate on Human Health and Blood Glucose Management
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.
Read the detailed description
Dietary fibre has several health benefits such as lowering the risks for cardiovascular disease, stroke, diabetes, obesity, and gastrointestinal diseases. Dietary fibre intake has regularly been reported to be below the daily recommended levels. Based on the 2010 National Nutrition Survey, 21% of Singaporeans did not meet the recommended daily intake of dietary fibre. While increasing fruit and vegetables intake remains the primary strategy to promote fibre intake, an alternative is to supplement a daily diet with dietary fibre, especially soluble fibre, to improve health.
Resistant dextrin is a non-viscous soluble fibre that exhibits prebiotic properties and it has been shown to alter gastrointestinal ecology. Emerging evidence suggests that resistant dextrin reduced insulin resistance in both healthy individuals and adults with type 2 diabetes, resulting in better blood glucose control. In term of its cardio-protective effects, resistant dextrin has also been shown to lower blood cholesterol levels and reduced inflammation biomarkers. Resistant dextrin has also been shown to suppress hunger and increase satiety, leading to reduced daily energy intake and greater body weight loss.
To date, evidence from clinical trials, notably among Asians is still insufficient to make dietary recommendations. In addition, the possibility of short-chain fatty acid production in stimulating diet-induced thermogenesis and fat oxidation has not been explored. These are the novel aspects that our proposed study aims to investigate.
- Conditions
- Nutrition, Healthy
- Being tested
- Control, Treatment
- Keywords
- resistant dextrin, glycaemic control, insulin sensitivity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Flavoured beverage powder with 3g glucose, twice a day Receives: Other: Control |
| Treatment | Experimental | Flavoured beverage powder with 20g resistant dextrin, twice a day Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.
Measured: 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).
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start14 Aug 2019
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Crossover assignment. Single-blinded, randomized, controlled, parallel arm trial with each participant block-randomized into either control or treatment group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554002
- Sponsor's protocol ID
- 2017/00558
- Other IDs
- 2017
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute-postprandial and Long-term Effects of Different Types of Carbohydrate on Human Health and Blood Glucose Management
- ClinicalTrials.gov ID
- NCT06554002
- Acronym / sponsor ID
- 2017/00558
- Conditions
- Nutrition, Healthy
- Keywords
- resistant dextrin, glycaemic control, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dietary fibre has several health benefits such as lowering the risks for cardiovascular disease, stroke, diabetes, obesity, and gastrointestinal diseases. Dietary fibre intake has regularly been reported to be below the daily recommended levels. Based on the 2010 National Nutrition Survey, 21% of Singaporeans did not meet the recommended daily intake of dietary fibre. While increasing fruit and vegetables intake remains the primary strategy to promote fibre intake, an alternative is to supplement a daily diet with dietary fibre, especially soluble fibre, to improve health.
Resistant dextrin is a non-viscous soluble fibre that exhibits prebiotic properties and it has been shown to alter gastrointestinal ecology. Emerging evidence suggests that resistant dextrin reduced insulin resistance in both healthy individuals and adults with type 2 diabetes, resulting in better blood glucose control. In term of its cardio-protective effects, resistant dextrin has also been shown to lower blood cholesterol levels and reduced inflammation biomarkers. Resistant dextrin has also been shown to suppress hunger and increase satiety, leading to reduced daily energy intake and greater body weight loss.
To date, evidence from clinical trials, notably among Asians is still insufficient to make dietary recommendations. In addition, the possibility of short-chain fatty acid production in stimulating diet-induced thermogenesis and fat oxidation has not been explored. These are the novel aspects that our proposed study aims to investigate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover assignment. Single-blinded, randomized, controlled, parallel arm trial with each participant block-randomized into either control or treatment group
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlFlavoured beverage powder with 3g glucose, twice a day |
| Treatment | Experimental | Other: TreatmentFlavoured beverage powder with 20g resistant dextrin, twice a day |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 21 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
Key exclusion criteria (15 listed)
- • Consume fibre supplements or any other supplements that is likely to interfere with study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants 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. | Other | Control |
| TreatmentParticipants 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. | Other | Treatment |
Primary outcome
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).
Time frame: Mid intervention visit on Week 4
Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.
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).
Time frame: Mid intervention visit on Week 4
Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.
Insulin sensitivity will be measured from fasting blood samples that will be collected at baseline and final visit.
Time frame: Mid intervention visit on Week 4
Fasting blood biochemistry from 14mL of venous blood sample collected via venipuncture.
24 hour glycaemic response will measured in all participants during the baseline and at the end of the intervention (at 8 weeks).
Time frame: Inserted on the Baseline visit (0 week) (Days 1-3) and Final visit (8 week) (Days 1-3)
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.
3 secondary outcomes
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).
Time frame: 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),
Time frame: 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.
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Nutrition, Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Mid intervention visit on Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.