NCT03533738

Brief Summary

The study hypothesizes that vegetable and protein consumed before a carbohydrate will reduce the glucose response. The vegetables and protein consumed before carbohydrate have different effects on insulin and satiety responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

July 17, 2020

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

May 11, 2018

Last Update Submit

July 16, 2020

Conditions

Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (2)

  • glycemic response

    using Hemocue analyzer

    up to 180 minutes

  • Insulin response

    using COBAS Analyzer

    up to 180 minutes

Study Arms (5)

Food selection 1

EXPERIMENTAL

To consume vegetables followed by meat \& rice together

Other: Food sequence 1

Food selection 2

EXPERIMENTAL

To consume meat followed by vegetables \& rice together

Other: Food sequence 2

Food selection 3

EXPERIMENTAL

To consume as follows: vegetables, meat, rice

Other: Food sequence 3

Food selection 4

EXPERIMENTAL

To consume vegetables followed by meat and rice together

Other: Food sequence 4

Food selection 5

EXPERIMENTAL

To consume rice followed by vegetables \& meat together

Other: Food sequence 5

Interventions

Food sequence 1OTHER

Vegetables first then meat \& rice together

Food selection 1
Food sequence 2OTHER

Meat first then vegetables \& rice together

Food selection 2
Food sequence 3OTHER

Vegetables first then meat followed by rice

Food selection 3
Food sequence 4OTHER

Vegetables first followed by meat and rice together

Food selection 4
Food sequence 5OTHER

Rice first followed by vegetables \& meat together

Food selection 5

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese ethnicity
  • Age between 21-40 years
  • Weight of at least 45 kg
  • Body mass index between 18 to 25 kg/m2
  • Normal blood pressure (≤140/90 mmHg)
  • Fasting blood glucose \<6.0 mmol/L

You may not qualify if:

  • Are a female who is pregnant
  • Partake in sports at the competitive and/or endurance levels
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Have major chronic disease such as heart disease, cancer or diabetes mellitus
  • Take insulin or drugs known to affect glucose metabolism
  • Intentionally restrict food intake
  • Have major medical or surgical event requiring hospitalization within the preceding 3 months
  • Have taken antibiotics for 3 months before the study period
  • Are a smoker
  • Are an overnight shift worker
  • Have any known food allergy (example anaphylaxis to peanuts)
  • 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
  • Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

  • Sun L, Goh HJ, Govindharajulu P, Leow MK, Henry CJ. Postprandial glucose, insulin and incretin responses differ by test meal macronutrient ingestion sequence (PATTERN study). Clin Nutr. 2020 Mar;39(3):950-957. doi: 10.1016/j.clnu.2019.04.001. Epub 2019 Apr 27.

    PMID: 31053510DERIVED

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: randomized crossover design
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

October 12, 2017

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

July 17, 2020

Record last verified: 2019-05

Locations

SG(1)