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

NCT ID: NCT06640335

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-19

Brief Summary

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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.

Detailed Description

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The proposed research is part of strategies to manipulate postprandial glycemia and generate weight-control-related benefits, such as promoting satiation. Literature has shown pre-loading caloric nutrients can change postprandial glycemia, but the mechanism is unclear. The investigators hypothesize that a small number of nutrients released in the small intestine can initiate physiological changes and develop feedback control to delay gastric emptying, leading to the delay in digestion of glycemic carbohydrates and the consequent moderate glycemic responses. The investigators propose to use potatoes as the testing glycemic carbohydrates, and the pre-load foods are green vegetables. The investigators will be testing the optimal preload time to achieve the highest control of glycemic response as well as the strongest effect in satiety induction. In addition, green vegetables will be consumed with or without a preload fat enhancer (canola oil) to investigate the mechanism behind significant preload compositions. Healthy adults will be instructed to eat the leafy vegetables first (with or without canola oil), followed by the potato foods (i.e., mashed potatoes). The measurement is the gastric emptying time, blood sugar concentration, insulin, and an appetite-related gut hormone GLP-1. In order to monitor gastric emptying using a non-invasive approach, a popular breath test used in children and a hydrogen breath test will be used to present the change of gastric emptying and the level of gut fermentation.

Results will demonstrate the mechanism of the impact of pre-loading nutrients on the digestion of glycemic carbohydrates. The goal is to eliminate the negative influence of glycemic carbohydrate consumption. Instead, to generate health benefits from dietary carbohydrates.

Conditions

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Postprandial Hyperglycemia Insulin High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control (All 24 participants)

Subjects consume 300 g of Russet Burbank mashed Potatoes

Group Type NO_INTERVENTION

No interventions assigned to this group

Co-ingestion (All 24 participants)

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

Group Type EXPERIMENTAL

Co-ingestion

Intervention Type OTHER

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

0 min preload (meal sequence) (10 participants)

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

Group Type EXPERIMENTAL

0 min preload

Intervention Type OTHER

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

5 min preload (10 participants)

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

Group Type EXPERIMENTAL

5 min preload

Intervention Type OTHER

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

10 min preload (10 participants)

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

Group Type EXPERIMENTAL

10 min preload

Intervention Type OTHER

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

15 min preload (10 participants)

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

Group Type EXPERIMENTAL

15 min preload

Intervention Type OTHER

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

20 min preload (10 participants)

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

Group Type EXPERIMENTAL

20 min preload

Intervention Type OTHER

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

Spinach only /10 min preload (All 24 participants)

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

Group Type EXPERIMENTAL

Spinach only / 10 min preload

Intervention Type OTHER

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

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

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

Group Type EXPERIMENTAL

10 min preload

Intervention Type OTHER

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

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

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

Group Type EXPERIMENTAL

Canola oil only / 10 min preload

Intervention Type OTHER

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

Interventions

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Co-ingestion

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

Intervention Type OTHER

0 min preload

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

Intervention Type OTHER

5 min preload

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

Intervention Type OTHER

10 min preload

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

Intervention Type OTHER

15 min preload

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

Intervention Type OTHER

20 min preload

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

Intervention Type OTHER

Spinach only / 10 min preload

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

Intervention Type OTHER

Canola oil only / 10 min preload

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alliance for Potato Research and Education

OTHER

Sponsor Role collaborator

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Amy Lin, PhD

Senior Principal Scientist I

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Clinical Nutrition Research Centre (CNRC)

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2021-095

Identifier Type: -

Identifier Source: org_study_id

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