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

Diabetes Clinical Trial

Official title:

Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Glycaemic Control and Gut Health in Singapore Adults With Metabolic Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05529108
• Other study ID #: S20
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: National University of Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• control biscuits
Consumption of plain biscuits everyday during intervention period.
• autoclaved BSG-containing biscuits
Consumption of autoclaved BSG-containing biscuits everyday during intervention period.
• bio-transformed BSG-containing biscuits
Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.

Locations

Country	Name	City	State
Singapore	NUS Department of Food Science & Technology	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Ministry of Education, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose concentration	Glucose concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in insulin concentration	Insulin concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in blood triglyceride concentration	Triglyceride concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in blood cholesterol concentration	Total cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration	Low-density Lipoprotein-cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in High-density Lipoprotein-cholesterol (HDL) concentration	High-density Lipoprotein-cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in Hemoglobin A1c (HbA1c) concentration	Hemoglobin A1c (HbA1c) concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in C-reactive protein concentration	C-reactive protein concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in IL-6 concentration	IL-6 concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in TNF-alpha concentration	TNF-alpha concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Primary	Change in gut microbiome composition	Gut microbiome composition in the fecal will be measured	Every 12 week (week 0 and week 12)
Primary	Change in short chain fatty acids concentration	Short chain fatty acids concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Primary	Change in bile acid concentration	Bile acid concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Secondary	Change in zonulin concentration	Zonulin concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Secondary	Change in calprotectin levels	Calprotectin concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Secondary	Change in appetite assessed by visual analogue scale	Visual analogue scale will be used to assess appetite.	Every 4 week (week 0, week 4, week 8 and week 12)
Secondary	Change in sleep quality by questionnaire	Questionnaire will be used to assess sleep quality	Every 4 week (week 0, week 4, week 8 and week 12)
Secondary	Change in weight and height	Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2	Every 4 week (week 0, week 4, week 8 and week 12)
Secondary	Change in blood pressure	Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.	Every 4 week (week 0, week 4, week 8 and week 12)
Secondary	Change in skin advanced glycation end products status	Skin advanced glycation end products status will be measured by a monitor.	Every 4 week (week 0, week 4, week 8 and week 12)
Secondary	Change in dietary	Questionnaire will be used to record dietary	Every 4 week (week 0, week 4, week 8 and week 12)