Type 2 Diabetes MellitusPuddingNCT02289612
Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products
A study testing Yellow Mustard Gum Fibre, Soluble Flaxseed Gum Fibre and Fenugreek Gum Fibre in people with Type 2 Diabetes Mellitus, run by University of Guelph at 1 site in Canada.
Trial summary
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Yellow Mustard Gum Fibre, Soluble Flaxseed Gum Fibre and Fenugreek Gum Fibre
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Oct 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men/Women
- Age 18-70 years
- CANRISK Questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes)
- BMI ≥25 and <40 kg/m2
- Prior use of acetaminophen
Who cannot join
- Smokers
- Food allergies or any life-threatening allergy (food or otherwise)
- Acetaminophen allergy
- Gastrointestinal conditions or illnesses (Including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD))
- Serious major medical condition (i.e. renal, liver)
- Pregnant or breastfeeding
Show all 12Show fewer
- Food Neophobia Scale score between 30 and 54 (Food Neophobia Scale is a questionnaire which is intended to screen out individuals who are unsure of consuming new products)
- TFEQ-CR >16 (TFEQ is a questionnaire to screen for restrained eaters)
- Alcohol consumption>4 drinks/sitting
- Medication or natural health products (NHPs) used for diabetes (glycemic control)
- Medication or NHPs contraindicated with acetaminophen
- Recent or intended significant weight loss or gain (i.e. >4 kg in previous 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pudding Study: The Effect of Effect of Fibre-enriched Pudding Products on Glycemic and Satiety Response in Adults at Risk for Type 2 Diabetes
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.
Read the detailed description
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Yellow Mustard Gum Fibre, Soluble Flaxseed Gum Fibre, Fenugreek Gum Fibre
- Keywords
- Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Mustard Gum FibreOther
Soluble Flaxseed Gum FibreOther
Fenugreek Gum FibreOther
| Study group | Role | What they receive |
|---|---|---|
| Tapioca Starch - Low-Fibre | Placebo comparator | Tapoica starch pudding without added fibre Receives: Other: Yellow Mustard Gum Fibre |
| High Maltose Corn Syrup - Low-Fibre | Placebo comparator | High maltose corn syrup pudding without added fibre Receives: Other: Yellow Mustard Gum Fibre |
| Trutol Glucose Beverage (#1) | Placebo comparator | Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit. Receives: Other: Yellow Mustard Gum Fibre |
| Trutol Glucose Beverage (#2) | Placebo comparator | Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit. Receives: Other: Yellow Mustard Gum Fibre |
| Yellow Mustard Gum Fibre - Tapioca Starch | Active comparator | Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. Receives: Other: Yellow Mustard Gum Fibre |
| Yellow Mustard Gum Fibre - High Maltose Corn Syrup | Active comparator | Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. Receives: Other: Yellow Mustard Gum Fibre |
| Soluble Flaxseed Gum Fibre - Tapioca Starch | Active comparator | Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. Receives: Other: Soluble Flaxseed Gum Fibre |
| Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup | Active comparator | Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. Receives: Other: Soluble Flaxseed Gum Fibre |
| Fenugreek Gum Fibre - Tapioca Starch | Active comparator | Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. Receives: Other: Fenugreek Gum Fibre |
| Fenugreek Gum Fibre - High Maltose Corn Syrup | Active comparator | Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. Receives: Other: Fenugreek Gum Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial blood glucose response for each pudding and control product
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Measured: Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Fasting and postprandial insulin response for each pudding and control product
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Measured: Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Fasting and postprandial acetaminophen absorption for each pudding and control product
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Measured: Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Satiety-producing effect for each pudding and control product
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.
Measured: Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Secondary outcomes (1)
3-Day food records
Participants will complete 3-day food records before the first treatment study visit to provide information about their background nutrient intake and dietary habits.
Measured: Over 3 days before the first treatment study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs, Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
- Investigators
- Alison M Duncan, Ph.D., R.D., Principal investigator, University of Guelph, Human Nutraceutical Research UnitAmanda J Wright, Ph.D., Study director, University of Guelph, Human Nutraceutical Research UnitAlison M Duncan, Ph.D., R.D., Study director, University of Guelph, Human Nutraceutical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289612
- Sponsor's protocol ID
- 14AP003
- Other IDs
- 200603
- Acronym
- Pudding
- Status last verified
- May 2018
- First submitted
- 5 Nov 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pudding Study: The Effect of Effect of Fibre-enriched Pudding Products on Glycemic and Satiety Response in Adults at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02289612
- Acronym / sponsor ID
- Pudding / 14AP003
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs, Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Agriculture and Agri-Food Canada
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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 purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.
Detailed description
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Tapioca Starch - Low-Fibre | Placebo comparator | Other: Yellow Mustard Gum FibreTapoica starch pudding without added fibre |
| High Maltose Corn Syrup - Low-Fibre | Placebo comparator | Other: Yellow Mustard Gum FibreHigh maltose corn syrup pudding without added fibre |
| Trutol Glucose Beverage (#1) | Placebo comparator | Other: Yellow Mustard Gum FibreTrutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit. |
| Trutol Glucose Beverage (#2) | Placebo comparator | Other: Yellow Mustard Gum FibreTrutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit. |
| Yellow Mustard Gum Fibre - Tapioca Starch | Active comparator | Other: Yellow Mustard Gum FibreYellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
| Yellow Mustard Gum Fibre - High Maltose Corn Syrup | Active comparator | Other: Yellow Mustard Gum FibreYellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
| Soluble Flaxseed Gum Fibre - Tapioca Starch | Active comparator | Other: Soluble Flaxseed Gum FibreSoluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
| Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup | Active comparator | Other: Soluble Flaxseed Gum FibreSoluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
| Fenugreek Gum Fibre - Tapioca Starch | Active comparator | Other: Fenugreek Gum FibreFenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
| Fenugreek Gum Fibre - High Maltose Corn Syrup | Active comparator | Other: Fenugreek Gum FibreFenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men/Women
- Age 18-70 years
- CANRISK Questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes)
- BMI ≥25 and <40 kg/m2
- Prior use of acetaminophen
Key exclusion criteria (12 listed)
- Smokers
- Food allergies or any life-threatening allergy (food or otherwise)
- Acetaminophen allergy
- Gastrointestinal conditions or illnesses (Including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD))
- Serious major medical condition (i.e. renal, liver)
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 |
|---|---|---|
| Yellow Mustard Gum Fibre | Other | High Maltose Corn Syrup - Low-Fibre, Tapioca Starch - Low-Fibre, Trutol Glucose Beverage (#1), Trutol Glucose Beverage (#2), Yellow Mustard Gum Fibre - High Maltose Corn Syrup, Yellow Mustard Gum Fibre - Tapioca Starch |
| Soluble Flaxseed Gum Fibre | Other | Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup, Soluble Flaxseed Gum Fibre - Tapioca Starch |
| Fenugreek Gum Fibre | Other | Fenugreek Gum Fibre - High Maltose Corn Syrup, Fenugreek Gum Fibre - Tapioca Starch |
Primary outcome
Fasting and postprandial blood glucose response for each pudding and control product
Time frame: Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial insulin response for each pudding and control product
Time frame: Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial acetaminophen absorption for each pudding and control product
Time frame: Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Satiety-producing effect for each pudding and control product
Time frame: Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.
1 secondary outcome
3-Day food records
Time frame: Over 3 days before the first treatment study visit
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 8 May 2018.
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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.
Alison M Duncan, Ph.D., R.D. principal investigator
University of Guelph, Human Nutraceutical Research Unit
Amanda J Wright, Ph.D. study director
University of Guelph, Human Nutraceutical Research Unit
Alison M Duncan, Ph.D., R.D. study director
University of Guelph, Human Nutraceutical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yellow Mustard Gum Fibre, Soluble Flaxseed Gum Fibre and Fenugreek Gum Fibre in people with Type 2 Diabetes Mellitus, run by University of Guelph at 1 site in Canada.
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 5 inclusion and 12 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 8 May 2018. 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 Canada. 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?
Fasting and postprandial blood glucose response for each pudding and control product (time frame: Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.). 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 8 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.