Metabolic Response Evaluation of Low-sugar Snack Bars

NCT04653220 | Completed

• 1 other identifier: 2019/00861
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the post-prandial metabolic response and biomarker response, following the consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are formulated with different combinations and ratios of ingredients and food structures. The low sugar products maintaining glucose homeostasis and preventing metabolic problems may have commercial potential as a novel functional ingredient in a variety of fields, including nutrition, medicine, and agriculture.

Conditions

Pre Diabetes; Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in postprandial blood glucose over 240 minutes period

  Venous Blood obtained through canula, analysed using Beckman Coulter analyser.

  240 minutes

Secondary Outcomes (5)

• Change in postprandial plasma insulin over 240 minutes period

  240 minutes

• Change in postprandial plasma triglycerides over 240 minutes period

  240 minutes

• Change in postprandial plasma non esterified fatty acids over 240 minutes period

  240 minutes

• Change in postprandial plasma active ghrelin over 240 minutes period

  240 minutes

• Change in postprandial plasma active GLP-1 over 240 minutes period

  240 minutes

Study Arms (8)

Control 1

OTHER

Glucose 25g

Other: Control 1

Control 2

OTHER

Glucose 25g

Other: Control 2

Standard Crokao

EXPERIMENTAL

Commercially available snack bar

Other: Standard Crokao

Low sugar variant 1

EXPERIMENTAL

Low sugar snack bar with sticky rice

Other: Low sugar variant 1

Low sugar variant 2

EXPERIMENTAL

Low sugar snack bar with promitor

Other: Low sugar variant 2

Low sugar variant 3

EXPERIMENTAL

Low sugar snack bar with inulin

Other: Low sugar variant 3

Low sugar variant 4

EXPERIMENTAL

Low sugar snack bar with yellow soy

Other: Low sugar variant 4

Low sugar variant 5

EXPERIMENTAL

Low sugar snack bar with rice syrup

Other: Low sugar variant 5

Interventions

Control 1 OTHER

25g glucose dissolve in 250ml of water

Control 1

Control 2 OTHER

25g glucose dissolve in 250ml of water

Control 2

Standard Crokao OTHER

Standard Crokao containing 25g of available carbohydrate

Standard Crokao

Low sugar variant 1 OTHER

Low sugar variant 1 containing 25g of available carbohydrate

Low sugar variant 1

Low sugar variant 2 OTHER

Low sugar variant 2 containing 25g of available carbohydrate

Low sugar variant 2

Low sugar variant 3 OTHER

Low sugar variant 3 containing 25g of available carbohydrate

Low sugar variant 3

Low sugar variant 4 OTHER

Low sugar variant 4 containing 25g of available carbohydrate

Low sugar variant 4

Low sugar variant 5 OTHER

Low sugar variant 5 containing 25g of available carbohydrate

Low sugar variant 5

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: All healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age between 21-65 years
• Chinese, Indian and Caucasian Ethnicity
• Body mass index between 18.5 - 25.5 kg/m2
• Fasting blood glucose \<7.0 mmol/L
• Normal blood pressure (\<140/90 mmHg)
• In general good health

You may not qualify if:

• Smoking
• Partake in sports at a high competitive and/or endurance levels
• Intentionally restrict food intakeHave known glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Have poor veins impeding venous access and have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
• Have metabolic diseases (such as diabetes, hypertension, etc.)
• have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
• Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug,
• Have any severe food allergy or food intolerance
• Having active Tuberculosis (TB) or currently receiving treatment for TB
• Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
• Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
• Concurrent participation in a study that might affect the outcomes of the current study

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized crossover study

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: November 13, 2019
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

SG (1)