Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome

National University of Singapore

Status: Active, not recruiting

Conditions: Diabetes; Metabolic Syndrome

Treatments: Dietary Supplement: control biscuits; Dietary Supplement: autoclaved BSG-containing biscuits; Dietary Supplement: bio-transformed BSG-containing biscuits

Study type: Interventional

Funder types: Other

Identifiers

NCT05529108

S20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

38 participants in 3 patient groups, including a placebo group

Control biscuits group

Placebo Comparator group

Description:

Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.

Treatment:

Dietary Supplement: control biscuits

autoclaved BSG-containing group

Experimental group

Description:

Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.

Treatment:

Dietary Supplement: autoclaved BSG-containing biscuits

bio-transformed BSG-containing group

Experimental group

Description:

Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period.

Treatment:

Dietary Supplement: bio-transformed BSG-containing biscuits