The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying

NCT06640335 | Active Not Recruiting

• 1 other identifier: 2021-095
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source.

Conditions

Postprandial Hyperglycemia; Insulin High

Outcome Measures

Primary Outcomes (3)

• Postprandial blood glucose

  Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Glucose levels are tested in the serum using cobas c311 analyzer.

  up to 3 hour (180 minutes) after test meal consumption

• Postprandial blood Insulin

  Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Insulin levels are tested in the serum using cobas e411 Immunoanalyzer.

  up to 3 hour (180 minutes) after test meal consumption

• Postprandial Glucagon Like Peptide -1 Total (GLP-1)

  Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. GLP-1 levels are tested in the plasma using GLP-1 Total ELISA kit (EZGLP1T-36K)

  up to 3 hour (180 minutes) after test meal consumption

Study Arms (10)

Control (All 24 participants)

NO INTERVENTION

Subjects consume 300 g of Russet Burbank mashed Potatoes

Co-ingestion (All 24 participants)

EXPERIMENTAL

Subjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time.

Other: Co-ingestion

0 min preload (meal sequence) (10 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes.

Other: 0 min preload

5 min preload (10 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes.

Other: 5 min preload

10 min preload (10 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Other: 10 min preload

15 min preload (10 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes.

Other: 15 min preload

20 min preload (10 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes.

Other: 20 min preload

Spinach only /10 min preload (All 24 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Other: Spinach only / 10 min preload

(Spinach + Canola oil) 10 min preload (All 24 participants)

EXPERIMENTAL

Subjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Other: 10 min preload

Canola oil only / 10 min preload (All 24 participants)

EXPERIMENTAL

Subjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Other: Canola oil only / 10 min preload

Interventions

Co-ingestion OTHER

Subjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time.

Co-ingestion (All 24 participants)

0 min preload OTHER

Subjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes.

0 min preload (meal sequence) (10 participants)

5 min preload OTHER

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes.

5 min preload (10 participants)

10 min preload OTHER

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

(Spinach + Canola oil) 10 min preload (All 24 participants); 10 min preload (10 participants)

15 min preload OTHER

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes.

15 min preload (10 participants)

20 min preload OTHER

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes.

20 min preload (10 participants)

Spinach only / 10 min preload OTHER

Subjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Spinach only /10 min preload (All 24 participants)

Canola oil only / 10 min preload OTHER

Subjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Canola oil only / 10 min preload (All 24 participants)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight \>/= 45 kg
• Normal blood pressure \</=120/80 mmH
• Fasting blood glucose of \<5.6 mmol/l
• Able to provide written informed consent before participating in the study.
• Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.

You may not qualify if:

• Smokers.
• Individuals with any metabolic diseases (such as diabetes, hypertension etc).
• Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
• Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
• Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
• Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug.
• Individuals with history of malabsorption due to mucosal disease, pancreatic disease, or other causes.
• Individuals with history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders).
• Individuals who are allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
• People who intentionally restrict food intake.
• People who consume excessive 13C rich products such as corn, sugar beet and pineapple.
• Individuals who partake in sports at the competitive and/or endurance levels
• Individuals who 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).
• Individuals who is a study team member or an immediate family of any study team member.
• Individuals who consume Excessive alcohol: consuming \>/= 6 alcoholic drinks per week.

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Clinical Nutrition Research Centre (CNRC)

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Hyperglycemia; Hyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Amy Lin, PhD

  Senior Principal Scientist I at Singapore Institute of Food and Biotechnology Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Scientist I

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: September 19, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)