NCT05529108Active, not recruitingNot Applicable

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

National University of Singapore2 sites in 1 country38 target enrollmentStarted: October 28, 2022Last updated: November 9, 2023

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: National University of Singapore
Enrollment: 38
Locations: 2
Primary Endpoint: Change in blood glucose concentration

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages: 35 Years to 85 Years (Adult, Older Adult)
Sex: All
Accepts 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)
•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