Clinical trial NCT05529108: Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Diabetes
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: 2022-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 12 week (week 0 and week 12)
measure: Change in insulin concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in blood triglyceride concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in blood cholesterol concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in High-density Lipoprotein-cholesterol (HDL) concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in Hemoglobin A1c (HbA1c) concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in C-reactive protein concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in IL-6 concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in TNF-alpha concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in gut microbiome composition
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in short chain fatty acids concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in bile acid concentration
timeFrame: Every 12 week (week 0 and week 12)
Secondary outcomes:
measure: Change in zonulin concentration
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in calprotectin levels
timeFrame: Every 12 week (week 0 and week 12)
measure: Change in appetite assessed by visual analogue scale
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
measure: Change in sleep quality by questionnaire
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
measure: Change in weight and height
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
measure: Change in blood pressure
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
measure: Change in skin advanced glycation end products status
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
measure: Change in dietary
timeFrame: Every 4 week (week 0, week 4, week 8 and week 12)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: NUS Department of Food Science & Technology
Study officials:
affiliation: Food Science and technology, Faculty of Science, National University of Singapore
name: Jung Eun Kim
role: PRINCIPAL_INVESTIGATOR
References: