Clinical trial NCT05421780: Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome
Official title: Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Diabetes
Diet Modification
Keywords: Metabolic Syndrome
middle-aged and older adults
Post-prandial Glycaemic response
bio-transformed food
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2022-06-16
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood glucose concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood insulin concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood triglyceride concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood cholesterol concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in High-density Lipoprotein-cholesterol (HDL) concentration
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood amino acid concentration
timeFrame: Every week (week 1, week 2 and week 3)
Secondary outcomes:
measure: Change in appetite assessed by visual analogue scale
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in breath CH4 and H2 concentrations
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in weight and height
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in waist circumference
timeFrame: Every week (week 1, week 2 and week 3)
measure: Change in blood pressure
timeFrame: Every week (week 1, week 2 and week 3)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yujing Xu
Study officials:
affiliation: Food Science and technology, Faculty of Science, National University of Singapore
name: Jung Eun Kim
role: PRINCIPAL_INVESTIGATOR
References: