Metabolic Response Evaluation of Low-sugar Snack Bars

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes; Pre Diabetes
• Intervention / Treatment: Other: Control 1; Other: Control 2; Other: Standard Crokao; Other: Low sugar variant 1; Other: Low sugar variant 2; Other: Low sugar variant 3; Other: Low sugar variant 4; Other: Low sugar variant 5

Detailed Description

In this study we will study and compare the postprandial metabolic response of 5 snack bar variants, 1 control product and 2 glucose (25g) reference drinks. The study will have a total of 8 test sessions in a non-blinded, crossover design. Online computer software will be used for simple randomization of the sequence of the 8 treatments (http://www.randomizer.org/).The 5 snack bars variants will be similar in macronutrient composition but will differ in the source of carbohydrate, fibre and protein (rice, bamboo, inulin, soy, promitor). They will be compared to a visually similar control product (crokao) that is higher in sugar. The reference drink will be anhydrous glucose (25g) dissolved in 250 ml of water.Study population: 15-20 participants will be recruited from each of the following ethnicities: Chinese, Indian and Caucasian. During the screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have with the researcher. The number of test sessions will be discussed between the researcher and the participants, depending on the volunteer's schedule. If they decide to take part in the study, they will be asked to sign the informed consent form. They will then be asked to complete a screening questionnaire and subsequently baseline measurements including anthropometric measurements, blood pressure, and fasting blood glucose will be collected from each participant in order to determine their eligibility. The screening questionnaire will include demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis (Tanita scale). Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage and hip circumference will be measured at the maximum protuberance of the buttocks. Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded.

Study protocol: The day before a test day, participants will be encouraged to consume their usual diet and avoid alcohol consumption and participating in vigorous exercise. On test days, participants will arrive at the laboratory after an overnight fast of 10 h. Upon arrival, participants will be asked to void, and have their weight and body fat assessed with a Tanita scale. After that, participants will enter the clinical suit and rest for 15 min before a blood catheter is inserted in the antecubital vein of the arm. After the blood catheter is inserted, participants will rest for 15 min, before two baseline blood sample (6 mL) are taken 10 minutes apart (-10 min and 0 min). Immediately after the second sample, participants will be served a test food that has to be consumed within 15 min. Subsequently blood samples (6mL) are obtained at 15, 30, 45, 60, 90,120, 180 and 240min. Appetite sensations (e.g. hunger, fullness, desire-to-eat etc.) will also be measured using questionnaires at similar time points when blood samples are taken. Subjects will be asked to rate their appetite sensations on a 100 mm visual analogue scale (VAS). After each session, the blood catheter will be removed. The participants will leave the laboratory and they will be asked to keep a food diary of what they eat for the remaining day. Participants will return until all test foods are consumed. During the entire test session, the subject will have to stay rested and in the laboratory. Television and a workspace will be provided to the subject.Blood samples will be will analysed for METABOLIC RESPONSE (glucose, insulin, Triglycerides, NEFA, GLP-1 and ghrelin). A 100 uL aliquot of blood during the first blood sample collection (T = -10min) will be obtained from each participant on the first day of treatment (thus only once) for baseline metabolomics profiling.A stool sample from each participant will be obtained to perform the following on the microbiome: DNA extraction, library prep, 16S and shotgun (whole genome) sequencing, and demultiplexing of genomic data. The stool sample will be collected between the screening session and the last test session (time of collection will not influence the sample analysis). The participant will be encouraged to collect the stool sample during one of the sessions at the research centre to eliminate transport of the sample.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeyakumar C Henry, PhD; Phone Number: 6407 0793; Email: jeya_henry@sifbi.a-star.edu.sg
• Study Contact Backup: Name: Stefan GJA Camps, PhD; Phone Number: 6407 4357; Email: Stefan_Camps@sifbi.a-star.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control 1; Glucose 25g	Other: Control 1; 25g glucose dissolve in 250ml of water
Other: Control 2; Glucose 25g	Other: Control 2; 25g glucose dissolve in 250ml of water
Experimental: Standard Crokao; Commercially available snack bar	Other: Standard Crokao; Standard Crokao containing 25g of available carbohydrate
Experimental: Low sugar variant 1; Low sugar snack bar with sticky rice	Other: Low sugar variant 1; Low sugar variant 1 containing 25g of available carbohydrate
Experimental: Low sugar variant 2; Low sugar snack bar with promitor	Other: Low sugar variant 2; Low sugar variant 2 containing 25g of available carbohydrate
Experimental: Low sugar variant 3; Low sugar snack bar with inulin	Other: Low sugar variant 3; Low sugar variant 3 containing 25g of available carbohydrate
Experimental: Low sugar variant 4; Low sugar snack bar with yellow soy	Other: Low sugar variant 4; Low sugar variant 4 containing 25g of available carbohydrate
Experimental: Low sugar variant 5; Low sugar snack bar with rice syrup	Other: Low sugar variant 5; Low sugar variant 5 containing 25g of available carbohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial blood glucose over 240 minutes period	Venous Blood obtained through canula, analysed using Beckman Coulter analyser.	240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial plasma insulin over 240 minutes period	Venous blood obtain through cannula, analysed using Beckman Coulter analyser.	240 minutes
Change in postprandial plasma triglycerides over 240 minutes period	Venous blood obtain through cannula, analysed using Beckman Coulter analyser.	240 minutes
Change in postprandial plasma non esterified fatty acids over 240 minutes period	Venous blood obtain through cannula, analysed using chemistry analyser.	240 minutes
Change in postprandial plasma active ghrelin over 240 minutes period	Venous blood obtain through cannula, analysed using ELISA analyser.	240 minutes
Change in postprandial plasma active GLP-1 over 240 minutes period	Venous blood obtain through cannula, analysed using ELISA analyser.	240 minutes

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 2019/00861

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No