Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02289612
• Date of registration: 05/11/2014
• Prospective Registration: No
• Primary sponsor: University of Guelph
• Public title: Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products Pudding
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02289612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Amanda J Wright, Ph.D.
• Affiliation: University of Guelph, Human Nutraceutical Research Unit

• Name: Alison M Duncan, Ph.D., R.D.
• Affiliation: University of Guelph, Human Nutraceutical Research Unit

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Other: Soluble Flaxseed Gum Fibre

Other: Fenugreek Gum Fibre

Other: Yellow Mustard Gum Fibre

Primary Outcome(s)

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.]

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.]

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.]

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.]

Secondary Outcome(s)

3-Day food records [Time Frame: Over 3 days before the first treatment study visit]

Secondary ID(s)

14AP003

200603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ontario Ministry of Agriculture, Food and Rural Affairs

Natural Sciences and Engineering Research Council, Canada

Agriculture and Agri-Food Canada

Dairy Farmers of Ontario