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 Singapore1 个研究点分布在 1 个国家目标入组 38 人开始时间: 2022年10月28日最近更新: 2023年11月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: National University of Singapore
入组人数: 38
试验地点: 1
主要终点: Change in short chain fatty acids concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 35 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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);

排除标准

•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

研究组 & 干预措施

Control biscuits group

Placebo Comparator

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

干预措施: control biscuits (Dietary Supplement)

autoclaved BSG-containing group

Experimental

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

干预措施: autoclaved BSG-containing biscuits (Dietary Supplement)

bio-transformed BSG-containing group

Experimental

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

干预措施: bio-transformed BSG-containing biscuits (Dietary Supplement)