Postprandial HyperglycemiaNCT04063137
Black Rice Anthocyanin in Mixed Meals: Influence on Postprandial Glycaemic and Lipid Responses Among Healthy Individuals
A study testing Anthocyanin fortified bread with beef patty (35% fat) in people with Postprandial Hyperglycemia and Lipidemia, run by National University of Singapore at 1 site in Singapore.
Trial summary
The diabetes epidemic is a pertinent concern globally. The prevalence of this metabolic disease among adults had been disclosed by the World health Organisation (WHO), reporting a total of 422 million diabetic adults and 3.7 million diabetic deaths in 2016, with Asian countries contributing more than 60% of the… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Lipidemia
- What is being tested?
- Anthocyanin fortified bread with beef patty (35% fat)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Sep 2019to 30 Dec 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Age between 21 - 65 years old.
- Healthy Body Mass Index (BMI) range of
- males: >=18.5 kg/m2 and <=24.9 kg/m2,
- females: >=18.5 kg/m2 and <=22.9 kg/m2.
- Overtly healthy males or females, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
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- Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
- Not on any regular medications (western/traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable. However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study.
- Have sufficient venous access to allow for blood sampling as per the protocol.
- Reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
- No dietary restriction to beef intake.
Who cannot join
- Persons with a history, or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data.
- Persons with electronic medical implants (e.g. pacemaker).
- Persons with known or ongoing psychiatric disorders within 3 years.
- Persons with regular use of known drugs of abuse within 3 years.
- Women who are pregnant or lactating.
- Persons who have donated more than 500 mL of blood 4 weeks prior to study enrolment.
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- Persons with an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females). 1 unit is equivalent to:
- 12 oz or 360 mL of beer;
- 5 oz or 150 mL of wine;
- 1.5 oz or 45 mL of distilled spirits.
- Persons with uncontrolled hypertension (i.e. blood pressure >160/100 mmHg)
- Persons with active infection(s) requiring systemic, antiviral or antimicrobial therapy that will not be completed prior to the first study visit.
- Persons who have undergone treatment with any investigational drug or biological agent within one (1) month of screening, or plans to enrol in another study involving investigational drugs/ biological agents during the duration of this study.
- Persons with a known allergy to insulin.
- Persons with a history of bleeding diathesis or coagulopathy.
- Persons with fasting glucose of >=126 mg/dL (>=7 mmol/L) or 2-hour postprandial glucose of >=200 mg/dL (>=11.1 mol/L).
- Persons with clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the subject or interfere with data integrity.
- Persons with any other conditions which, in the opinion of the Investigator, would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study.
- Persons with significant change in weight (+/- 5%) during the past month.
Trial locations and contacts
1 site in 1 country.
About this study
The diabetes epidemic is a pertinent concern globally. The prevalence of this metabolic disease among adults had been disclosed by the World health Organisation (WHO), reporting a total of 422 million diabetic adults and 3.7 million diabetic deaths in 2016, with Asian countries contributing more than 60% of the world's diabetic population. Due to its economic and social repercussions, preventive strategies are implemented at a population level. The implementation of a diet low in glycaemic index (GI) has been widely adopted as part of diabetes management strategies to prevent and control Type 2 Diabetes Mellitus (T2DM) as the consumption of food with low GI has shown to improve glycaemic control, lipid profile, and reduce systemic inflammation. Other strategies include adopting an active lifestyle and the consumption of functional foods. In lieu of this, the composition of food products may be altered by incorporating edible plant-based functional components with carbohydrase-inhibiting properties. Black rice has been proposed as a viable source of functional ingredients, namely anthocyanins, not only because of its potential benefits to health that has been established by numerous in-vitro studies, but also it is easily sourced for in Asia as it is widely cultivated.
In this study, black rice anthocyanin-fortified bread serves as a replacement to white bread as the staple to the subject's diet, in a mixed meal setting. The fortified bread is hypothesised to improve glycemic responses over white bread, offering a lower GI food alternative to the conventional staple.
Read the detailed description
Black rice anthocyanin-fortified bread, compared to white bread as a control, is hypothesised to improve glycaemic control and serum lipid profiles in a mixed meal setting. The aim of this research is to to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.
The aim of the research is to contribute to the prevention of diabetes by investigating how the incorporation of functional ingredients in carbohydrate-based foods will influence glycaemic and lipid panel profiles in a mixed meal setting. A human in-vivo intervention study will be conducted to assess the glycaemic and lipid responses of anthocyanin-fortified bread as compared to white bread, served with a ground beef patty to simulate the mixed meal. The approximate time to complete study recruitment will be 4 weeks.
Healthy, non-smoking subjects aged 21 to 65 will be recruited in this study. There will be a total of 2 visits (excluding 1 screening session), with the duration of each visit approximately 4-5 h. The study procedures will be conducted in Investigational Medicine Unit (IMU). During the each visit, subjects will undergo a mixed meal tolerance test. Test foods will be freshly prepared on the day of the visit in Food Science amp; Technology Programme food preparation area situated at Block S14 level 5, Science Drive 2, using food-grade ingredients. Only small quantities of bread will be prepared each day (3 to 4). The subject's glycemic response to the control meal (white bread) will be compared to their response after consumption of anthocyanin-fortified bread in a mixed meal setting. An improvement in postprandial blood glucose response and lipid panel profiles in response to the mixed meals will show that the anthocyanin-fortification is effective in offering better control over glycaemic and lipid profiles.
- Conditions
- Postprandial Hyperglycemia, Lipidemia
- Being tested
- Anthocyanin fortified bread with beef patty (35% fat)
- Keywords
- Black rice, Anthocyanin, Lipidemia, High-fat diet
- Medical subject headings
- Hyperglycemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanin fortified bread with beef patty (35% fat)Dietary supplement
Bread is fortified at a 4% level using 25% (w/w) anthocyanin black rice extract. It is served with a beef patty (35% fat) to simulate a high-fat diet.
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanin fortified bread | Active comparator | White bread is fortified with a 25% (w/w) black rice anthocyanin extract. Extract fortification is 4% w/w of bread flour. Receives: Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat) |
| White bread | Placebo comparator | Not described Receives: Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under curve for Low-density lipoprotein cholesterol (LDL-c)
mmol/L*min; area under curve
Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.
Secondary outcomes (1)
Change in area under curve for Blood glucose
mmol/L*min; area under curve
Measured: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start16 Sep 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a within-subject cross-over trial design to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Health System, Singapore
- Responsible party
- Principal investigator, Mei Hui Liu, National University of Singapore
- Investigators
- Mei Hui Liu, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063137
- Sponsor's protocol ID
- 2018/00971
- Other IDs
- 2018
- Status last verified
- Jul 2021
- First submitted
- 20 Jun 2019
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be decided on a later date.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Rice Anthocyanin in Mixed Meals: Influence on Postprandial Glycaemic and Lipid Responses Among Healthy Individuals
- ClinicalTrials.gov ID
- NCT04063137
- Acronym / sponsor ID
- 2018/00971
- Conditions
- Postprandial Hyperglycemia, Lipidemia
- Keywords
- Black rice, Anthocyanin, Lipidemia, High-fat diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Health System, Singapore
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Aug 2019 (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.
The diabetes epidemic is a pertinent concern globally. The prevalence of this metabolic disease among adults had been disclosed by the World health Organisation (WHO), reporting a total of 422 million diabetic adults and 3.7 million diabetic deaths in 2016, with Asian countries contributing more than 60% of the world's diabetic population. Due to its economic and social repercussions, preventive strategies are implemented at a population level. The implementation of a diet low in glycaemic index (GI) has been widely adopted as part of diabetes management strategies to prevent and control Type 2 Diabetes Mellitus (T2DM) as the consumption of food with low GI has shown to improve glycaemic control, lipid profile, and reduce systemic inflammation. Other strategies include adopting an active lifestyle and the consumption of functional foods. In lieu of this, the composition of food products may be altered by incorporating edible plant-based functional components with carbohydrase-inhibiting properties. Black rice has been proposed as a viable source of functional ingredients, namely anthocyanins, not only because of its potential benefits to health that has been established by numerous in-vitro studies, but also it is easily sourced for in Asia as it is widely cultivated.
In this study, black rice anthocyanin-fortified bread serves as a replacement to white bread as the staple to the subject's diet, in a mixed meal setting. The fortified bread is hypothesised to improve glycemic responses over white bread, offering a lower GI food alternative to the conventional staple.
Detailed description
Black rice anthocyanin-fortified bread, compared to white bread as a control, is hypothesised to improve glycaemic control and serum lipid profiles in a mixed meal setting. The aim of this research is to to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.
The aim of the research is to contribute to the prevention of diabetes by investigating how the incorporation of functional ingredients in carbohydrate-based foods will influence glycaemic and lipid panel profiles in a mixed meal setting. A human in-vivo intervention study will be conducted to assess the glycaemic and lipid responses of anthocyanin-fortified bread as compared to white bread, served with a ground beef patty to simulate the mixed meal. The approximate time to complete study recruitment will be 4 weeks.
Healthy, non-smoking subjects aged 21 to 65 will be recruited in this study. There will be a total of 2 visits (excluding 1 screening session), with the duration of each visit approximately 4-5 h. The study procedures will be conducted in Investigational Medicine Unit (IMU). During the each visit, subjects will undergo a mixed meal tolerance test. Test foods will be freshly prepared on the day of the visit in Food Science amp; Technology Programme food preparation area situated at Block S14 level 5, Science Drive 2, using food-grade ingredients. Only small quantities of bread will be prepared each day (3 to 4). The subject's glycemic response to the control meal (white bread) will be compared to their response after consumption of anthocyanin-fortified bread in a mixed meal setting. An improvement in postprandial blood glucose response and lipid panel profiles in response to the mixed meals will show that the anthocyanin-fortification is effective in offering better control over glycaemic and lipid profiles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a within-subject cross-over trial design to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.
| Arm | Type | Receives |
|---|---|---|
| Anthocyanin fortified bread | Active comparator | Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat)White bread is fortified with a 25% (w/w) black rice anthocyanin extract. Extract fortification is 4% w/w of bread flour. |
| White bread | Placebo comparator | Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to give informed consent.
- Age between 21 - 65 years old.
- Healthy Body Mass Index (BMI) range of
- Overtly healthy males or females, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
Key exclusion criteria (19 listed)
- Persons with a history, or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data.
- Persons with electronic medical implants (e.g. pacemaker).
- Persons with known or ongoing psychiatric disorders within 3 years.
- Persons with regular use of known drugs of abuse within 3 years.
- Women who are pregnant or lactating.
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 |
|---|---|---|
| Anthocyanin fortified bread with beef patty (35% fat)Bread is fortified at a 4% level using 25% (w/w) anthocyanin black rice extract. It is served with a beef patty (35% fat) to simulate a high-fat diet. | Dietary supplement | Anthocyanin fortified bread, White bread |
Primary outcome
Change in area under curve for Low-density lipoprotein cholesterol (LDL-c)
Time frame: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.
mmol/L*min; area under curve
1 secondary outcome
Change in area under curve for Blood glucose
Time frame: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.
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 15 Nov 2024.
- Individual participant dataSharing planned: No. Will be decided on a later date.
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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.
Mei Hui Liu principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthocyanin fortified bread with beef patty (35% fat) in people with Postprandial Hyperglycemia and Lipidemia, run by National University of Singapore 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 11 inclusion and 19 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 15 Nov 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. Some participants in this study may receive a placebo. 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?
Change in area under curve for Low-density lipoprotein cholesterol (LDL-c) (time frame: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.). 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 15 Nov 2024.