跳至主要内容
临床试验/NCT05421780
NCT05421780进行中(未招募)不适用

Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome

National University of Singapore2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
16
试验地点
2
主要终点
Change in blood triglyceride concentration

研究概览

简要总结

The purpose of this study is to assess the glycaemic controlling effects of BSG and bio-transformed BSG-containing biscuits in Singapore adults with MetS. The investigators hypothesized that consumption of BSG and bio-transformed BSG containing biscuit will improve glycaemic control.

详细描述

This is a double-blind, randomised, crossover experiment. During the 3-week, 19 subjects will participate in a 3 meal tolerance test (MTT). During each MTT session, all subjects are required to consume 90 g biscuits (either control, autoclaved BSG or bio-transformed BSG biscuits) and monitored over a period of 240 minutes. All three types of biscuits will be consumed at a randomised sequence during this 3-week period. Post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (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

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

结局指标

主要结局

Change in blood triglyceride concentration

时间窗: Every week (week 1, week 2 and week 3)

Triglyceride concentration in the blood will be measured

Change in blood amino acid concentration

时间窗: Every week (week 1, week 2 and week 3)

Amino acid concentration in the blood will be measured

Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration

时间窗: Every week (week 1, week 2 and week 3)

Low-density Lipoprotein-cholesterol concentration in the blood will be measured

Change in blood glucose concentration

时间窗: Every week (week 1, week 2 and week 3)

Glucose concentration in the blood will be measured

Change in blood insulin concentration

时间窗: Every week (week 1, week 2 and week 3)

Insulin concentration in the blood will be measured

Change in High-density Lipoprotein-cholesterol (HDL) concentration

时间窗: Every week (week 1, week 2 and week 3)

High-density Lipoprotein-cholesterol concentration in the blood will be measured

Change in blood cholesterol concentration

时间窗: Every week (week 1, week 2 and week 3)

Total cholesterol concentration in the blood will be measured

次要结局

  • Change in appetite assessed by visual analogue scale(Every week (week 1, week 2 and week 3))
  • Change in breath CH4 and H2 concentrations(Every week (week 1, week 2 and week 3))
  • Change in waist circumference(Every week (week 1, week 2 and week 3))
  • Change in blood pressure(Every week (week 1, week 2 and week 3))
  • Change in weight and height(Every week (week 1, week 2 and week 3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung Eun Kim

Assistant Professor

National University of Singapore

研究点 (2)

Loading locations...

相似试验