NCT05143060

Brief Summary

This study choosed good health, aged 18 \~ 25, physical standard, the glucose tolerance test normal adults 12, oral glucose (reference) respectively in different periods, the valley of fiber powder upgrade formula, perfect meals, by extraction shu cereal bars, light appearance suits (by extraction shu compound dietary fiber powder, feeding combination 1:1) and 17 extraction enzyme 6 kinds of food, Venous blood was collected 15, 30, 45, 60, 90 and 120 min before and after oral administration respectively. Blood was collected for 7 times with 2mL each. The plasma is then separated to determine glucose levels. Blood glucose was measured within 3 h. With glucose as the reference, food glycemic index (GI) was calculated using the internationally used Wolever method. Time was taken as abscissa and blood glucose value at each time point was taken as ordinate to prepare the blood glucose response curve of each food tested after eating. The elevated glycemic area (AUC) under the glycemic curve was calculated geometrically, and the food GI and glycemic load (GL) values were calculated according to the following formula: GI value = (2 h post-meal blood glucose AUC of the tested food / 2 h post-meal glucose glucose AUC of the same amount of carbohydrate)×100, GL=GI\*M(100g of the actual available carbohydrate of a food)/100.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 22, 2021

Last Update Submit

December 2, 2021

Conditions

Glycemic Index

Keywords

Glycemic IndexGlycemic Load

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Venous blood was collected up to 120 min

    Blood glucose was measured within 3 hours.

Study Arms (2)

Cereal fiber powder

EXPERIMENTAL

Cereal fiber powder

Dietary Supplement: Cereal powder

Pure glucose powder

PLACEBO COMPARATOR

Pure glucose powder

Dietary Supplement: Pure glucose powder

Interventions

Cereal powderDIETARY_SUPPLEMENT

Eat or drink oral glucose (reference) the valley of fiber powder upgrade formula, perfect meals, by extraction shu cereal bars, light appearance suits (by extraction shu compound dietary fiber powder, feeding combination 1:1) and 17 extraction enzyme 6 kinds of food respectively in different periods.

Also known as: perfect meals, 17 extraction enzyme
Cereal fiber powder
Pure glucose powderDIETARY_SUPPLEMENT

Pure glucose powder

Pure glucose powder

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, normal glucose tolerance test, normal blood pressure, no family history of diabetes or other metabolic history;
  • Aged between 18 and 25;
  • Normal body weight and waist circumference, body mass index (BMI) between 18.5 and 23.9kg/m2;
  • No carbohydrate intolerance.

You may not qualify if:

  • Those with abnormal glucose tolerance, overweight or obese, or lactose or carbohydrate intolerance were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

Location

Related Publications (3)

  • Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.

    PMID: 6259925BACKGROUND

  • Vrolix R, Mensink RP. Variability of the glycemic response to single food products in healthy subjects. Contemp Clin Trials. 2010 Jan;31(1):5-11. doi: 10.1016/j.cct.2009.08.001. Epub 2009 Sep 6.

    PMID: 19737630BACKGROUND

  • Barclay AW, Petocz P, McMillan-Price J, Flood VM, Prvan T, Mitchell P, Brand-Miller JC. Glycemic index, glycemic load, and chronic disease risk--a meta-analysis of observational studies. Am J Clin Nutr. 2008 Mar;87(3):627-37. doi: 10.1093/ajcn/87.3.627.

    PMID: 18326601BACKGROUND

Study Officials

  • Chen C gang, Master

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 3, 2021

Study Start

April 1, 2021

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations

CN(1)