Diabetes, Metabolic Syndrome
Conditions
Keywords
Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
Brief summary
The purpose of this research project is to assess the glycaemic controlling effects of consuming BSG and bio-transformed BSG-containing biscuits and its underlying gut - related mechanism in adults with MetS using in-vivo setting.
Detailed description
This is a double-blind, randomised, parallel experiment, all subjects (38 adults in Singapore with MetS) will complete a 12-week intervention period. Subjects will be randomly assigned to consume their habitual diet with biscuit that either does not contain or contains autoclaved BSG or bio-transformed BSG for 12 weeks. Throughout the intervention, subjects will be assessed for glucose, insulin, lipid and amino acid responses, biomarkers of gut health, and as well as other markers of health.
Interventions
DIETARY_SUPPLEMENTcontrol biscuits
Consumption of plain biscuits everyday during intervention period.
DIETARY_SUPPLEMENTautoclaved BSG-containing biscuits
Consumption of autoclaved BSG-containing biscuits everyday during intervention period.
DIETARY_SUPPLEMENTbio-transformed BSG-containing biscuits
Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.
Sponsors
Ministry of Education, Singapore
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants, aged 35-85 years old * English-literate and able to give informed consent in English * Willing to follow the study procedures * Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference \> 102 cm (male), \> 88 cm (female) (For Asian population: Waist circumference \> 90 cm (male), \> 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) \< 40 mg/dL (male), \< 50 mg/dL (female); systolic or diastolic blood pressure \> 130/85 mmHg or on medication);
Exclusion criteria
* Significant change in weight (≥ 3 kg body weight) during the past 3 months * Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits. * Acute illness at the study baseline * Exercising vigorously\* over the past 3 months. \*Defined as having \> 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day * Following any restricted diet (e.g. vegetarian) * Smoking * Have a daily intake of more than 2 alcoholic drinks per day * Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.) * Consumption of antibiotics over past 3 months. * Pregnant, lactating, or planning pregnancy in the next 6 months * Insufficient venous access to allow the blood collection * Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation * High current intake of fibre\* from brown rice or wholemeal products. \*High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines * High current intake of fibre\* from vegetables. \* High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bile acid concentration | Every 12 week (week 0 and week 12) | Bile acid concentration in the fecal will be measured |
| Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration | Every 12 week (week 0 and week 12) | Low-density Lipoprotein-cholesterol concentration in the blood will be measured |
| Change in High-density Lipoprotein-cholesterol (HDL) concentration | Every 12 week (week 0 and week 12) | High-density Lipoprotein-cholesterol concentration in the blood will be measured |
| Change in Hemoglobin A1c (HbA1c) concentration | Every 12 week (week 0 and week 12) | Hemoglobin A1c (HbA1c) concentration in the blood will be measured |
| Change in C-reactive protein concentration | Every 12 week (week 0 and week 12) | C-reactive protein concentration in the blood will be measured |
| Change in IL-6 concentration | Every 12 week (week 0 and week 12) | IL-6 concentration in the blood will be measured |
| Change in TNF-alpha concentration | Every 12 week (week 0 and week 12) | TNF-alpha concentration in the blood will be measured |
| Change in gut microbiome composition | Every 12 week (week 0 and week 12) | Gut microbiome composition in the fecal will be measured |
| Change in short chain fatty acids concentration | Every 12 week (week 0 and week 12) | Short chain fatty acids concentration in the fecal will be measured |
| Change in blood glucose concentration | Every 12 week (week 0 and week 12) | Glucose concentration in the blood will be measured |
| Change in insulin concentration | Every 12 week (week 0 and week 12) | Insulin concentration in the blood will be measured |
| Change in blood triglyceride concentration | Every 12 week (week 0 and week 12) | Triglyceride concentration in the blood will be measured |
| Change in blood cholesterol concentration | Every 12 week (week 0 and week 12) | Total cholesterol concentration in the blood will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight and height | Every 4 week (week 0, week 4, week 8 and week 12) | Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m\^2 |
| Change in zonulin concentration | Every 12 week (week 0 and week 12) | Zonulin concentration in the fecal will be measured |
| Change in calprotectin levels | Every 12 week (week 0 and week 12) | Calprotectin concentration in the fecal will be measured |
| Change in appetite assessed by visual analogue scale | Every 4 week (week 0, week 4, week 8 and week 12) | Visual analogue scale will be used to assess appetite. |
| Change in blood pressure | Every 4 week (week 0, week 4, week 8 and week 12) | Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor. |
| Change in skin advanced glycation end products status | Every 4 week (week 0, week 4, week 8 and week 12) | Skin advanced glycation end products status will be measured by a monitor. |
| Change in dietary | Every 4 week (week 0, week 4, week 8 and week 12) | Questionnaire will be used to record dietary |
| Change in sleep quality by questionnaire | Every 4 week (week 0, week 4, week 8 and week 12) | Questionnaire will be used to assess sleep quality |
Countries
Singapore
Outcome results
None listed