NCT02927600

Brief Summary

The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic Responses (GR) interventions at breakfast or at dinner is the most effective for lowering glycemic response of the subsequent standard meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable healthy

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

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

September 14, 2016

Last Update Submit

November 9, 2017

Conditions

Healthy

Keywords

Glycemic responseGlycemic indexMeal interventionChinese population

Outcome Measures

Primary Outcomes (1)

  • Glycemia

    Incremental areas under curve (iAUC) of glycemia in the 3 hours following meal intake

    3 hours

Secondary Outcomes (8)

  • Glycemia

    24h

  • Plasma glucagon

    3 hours

  • Plasma insulin

    3 hours post meal intake

  • Plasma triglycerides

    3 hours post meal intake

  • Plasma glycerol

    3 hours post meal intake

  • +3 more secondary outcomes

Study Arms (4)

Low GI Rice Breakfast

EXPERIMENTAL

Intake of low GI breakfast

Other: Low GI Breakfast

High GI rice Breakfast

EXPERIMENTAL

Intake of High GI breakfast

Other: High GI Breakfast

Low GI Rice Dinner

EXPERIMENTAL

Intake of low GI dinner

Other: Low GI Dinner

High GI Rice Dinner

EXPERIMENTAL

Intake of High GI dinner

Other: High GI Dinner

Interventions

Low GI BreakfastOTHER

Intake of low GI breakfast

Low GI Rice Breakfast
High GI BreakfastOTHER

Intake of high GI breakfast

High GI rice Breakfast
Low GI DinnerOTHER

Intake of Low GI dinner

Low GI Rice Dinner
High GI DinnerOTHER

Intake of high GI dinner

High GI Rice Dinner

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 50 to ≤ 70 years old years
  • Chinese male and female healthy subjects having both grandparents Chinese
  • Body mass index: ≥ 18.5 to ≤ 24.9kg/m2
  • Waist circumference ≤90 cm for males and ≤ 85 cm for females
  • Systolic blood pressure \<150 mmHg; Diastolic blood pressure \<90 mmHg
  • Willing and able to sign written informed consent prior to trial entry

You may not qualify if:

  • Known Diabetes type 2, under medication
  • Fasting Glycemia \> 7 mmol/L
  • Any clinically relevant gastrointestinal (ulcer, malabsorption), renal (insufficiency), cardiovascular (stroke, arterial hypertension, heart disease), metabolic disease (dyslipidemia), psychiatric disorder (depression) that would affect the study in the opinion of the CNRC clinician, according to a detailed medical history and a blood sampling at screening, only if deemed necessary by CNRC clinician.
  • Anemia (anamnesis)
  • Subjects who had a history of major gastrointestinal surgery
  • Subjects who had more than 5% weight loss from baseline weight during the past three months (more than 5% of initial weight)
  • Present drug abuse or use of medications that could interfere with the treatment or energetic metabolism including corticosteroids, growth hormone, hormonal replacement therapy, anti-hypertensives like ACE inhibitor, thiazides and angiotensin receptors blockers. These conditions will be screened based on subject reporting. Participants will be asked to bring in their current medications at the time of screening, and these will be checked by the study-staff.
  • Subject allergic /intolerant to any of the test foods or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings etc.
  • Subject on special diets especially vegetarian, high protein or weight loss program.
  • Current smokers (i.e. people having smoked in the month preceding the enrolment)
  • Subjects having a high alcohol consumption (more than 2 drinks/day)
  • Subjects who are not willing and not able to comply with scheduled visits and the requirements of the study procedures in the opinion of the investigators.
  • Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Singapore, 117599, Singapore

Location

Related Publications (1)

  • Haldar S, Egli L, De Castro CA, Tay SL, Koh MXN, Darimont C, Mace K, Henry CJ. High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Apr;8(1):e001099. doi: 10.1136/bmjdrc-2019-001099.

    PMID: 32327444DERIVED

Study Officials

  • Christiani Jeyakumar Henry, Prof

    Centre for Translational Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

October 7, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)