Status:
UNKNOWN
Food Based Intervention Rich in Plant Components to Improve Metabolic Health in Prediabetics (FBIP) Study
Lead Sponsor:
Singapore Institute of Food and Biotechnology Innovation
Conditions:
Diabetes
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
The estimated prevalence of type 2 diabetes and prediabetes in Singapore will be approximately 20% and 25% respectively by the year 2035. Therefore, effective population based interventions are urgent...
Detailed Description
The worldwide prevalence of type 2 diabetes has increased by more than two-fold over the past three decades, with \~60% of diabetics in the world currently living in Asian countries. Type 2 diabetes o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Chinese Male or Female• Age between 45-75 years
- Body mass index 19.5-32.0 kg/m2
- Deemed to be prediabetic based on meeting any 1 of 3 following criteria:1. Fasting blood glucose \>5.5 mmol/l and \<7.0 mmol/l2. Oral glucose tolerance test (OGTT) level \>/=7.8 mmol/l and \</=11.0 mmol/l3. Haemoglobin A1c (HbA1c) level \>/=5.7 and \</=6.4%.
- Exclusion criteria:
- Smoking
- Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
- Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
- Not willing to adhere to diet modification as in the study protocol
- Not willing to stop any strenuous activity during or within 24 hours of test days (for those actively participating in sports at the competitive and/or endurance levels)
- Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week
- Having sustained elevation of blood pressure (\>160/95 mm Hg)
- Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
- Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
- Diabetic
- Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
- Having any prescription medication or any other alternative medicines or supplements which may interfere with study measurements in the in the opinion of the study investigators
- Having antibiotics or suffering from diarrhea within the last 3 months
- Having donated blood within 4 weeks of study participation
- Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws
- Having more than 5% weight loss or gain over the past 3 months
- For female volunteers: menstruation within past 12 months or being on hormone replacement therapy
Exclusion
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04745702
Start Date
November 2 2020
End Date
August 9 2022
Last Update
March 11 2022
Active Locations (1)
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1
Clinical Nutrition Research Centre
Singapore, Singapore, 117599