Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome

NCT05529108 | Unknown

• 1 other identifier: S20
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Diabetes

Keywords

Metabolic Syndrome; middle-aged and older adults; Post-prandial Glycaemic response; bio-transformed food

Outcome Measures

Primary Outcomes (13)

• Change in blood glucose concentration

  Glucose concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in insulin concentration

  Insulin concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in blood triglyceride concentration

  Triglyceride concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in blood cholesterol concentration

  Total cholesterol concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

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

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

  Every 12 week (week 0 and week 12)

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

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

  Every 12 week (week 0 and week 12)

• Change in Hemoglobin A1c (HbA1c) concentration

  Hemoglobin A1c (HbA1c) concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in C-reactive protein concentration

  C-reactive protein concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in IL-6 concentration

  IL-6 concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in TNF-alpha concentration

  TNF-alpha concentration in the blood will be measured

  Every 12 week (week 0 and week 12)

• Change in gut microbiome composition

  Gut microbiome composition in the fecal will be measured

  Every 12 week (week 0 and week 12)

• Change in short chain fatty acids concentration

  Short chain fatty acids concentration in the fecal will be measured

  Every 12 week (week 0 and week 12)

• Change in bile acid concentration

  Bile acid concentration in the fecal will be measured

  Every 12 week (week 0 and week 12)

Secondary Outcomes (8)

• Change in zonulin concentration

  Every 12 week (week 0 and week 12)

• Change in calprotectin levels

  Every 12 week (week 0 and week 12)

• Change in appetite assessed by visual analogue scale

  Every 4 week (week 0, week 4, week 8 and week 12)

• Change in sleep quality by questionnaire

  Every 4 week (week 0, week 4, week 8 and week 12)

• Change in weight and height

  Every 4 week (week 0, week 4, week 8 and week 12)

Study Arms (3)

Control biscuits group

PLACEBO COMPARATOR

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

Dietary Supplement: control biscuits

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.

Dietary Supplement: autoclaved BSG-containing biscuits

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.

Dietary Supplement: bio-transformed BSG-containing biscuits

Interventions

control biscuits DIETARY_SUPPLEMENT

Consumption of plain biscuits everyday during intervention period.

Control biscuits group

autoclaved BSG-containing biscuits DIETARY_SUPPLEMENT

Consumption of autoclaved BSG-containing biscuits everyday during intervention period.

autoclaved BSG-containing group

bio-transformed BSG-containing biscuits DIETARY_SUPPLEMENT

Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.

bio-transformed BSG-containing group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Ministry of Education, Singapore: collaborator

Study Sites (1)

NUS Department of Food Science & Technology

Singapore, 117551, Singapore

Location

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jung Eun Kim

  Food Science and technology, Faculty of Science, National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: October 28, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)