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Glycemic IndexNCT05143060

Determination of Glycemic Index and Glycemic Load of Cereal Fiber Powder

A study testing Cereal powder and Pure glucose powder in people with Glycemic Index, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Glycemic Index
What is being tested?
Cereal powder and Pure glucose powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteChina
Study dates
1 Apr 2021to 10 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510030

Other trials in China

About this study

Official title: Study on the Determination of Glycemic Index and Glycemic Load of Cereal Fiber Powder

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.

Read the detailed description

(I) Glucose test: twelve subjects began to fast at 10 PM the previous day, and 2mL of venous blood was collected on an empty stomach in the morning of the next day, which was divided into sodium fluoride anticoagulant tubes for measuring glucose. Then 25 g of pure glucose powder was taken orally, and venous blood was taken at 15, 30, 45, 60, 90 and 120 min, respectively. A total of 7 blood samples were collected, and 2mL of blood was collected each time. Then the plasma was separated to determine the content of glucose, and the blood glucose was measured within 3 h. In this study, venous indwelling needle was used to collect blood, which can reduce repeated venous aspiration. About 2 mL of normal saline was left in the indwelling needle to prevent blood clotting. Blood collection by an experienced nurse in charge or supervising nurse.

(II) Glucose response test of tested foods: Glucose test was conducted on the first day, and different tested foods (see Table 2 and Table 3) were tested on the third, sixth or ninth day respectively, with an interval of 2-3 days or more between the two foods. Specific dates were arranged according to the test schedule. Twelve subjects fasted after 10:00 PM the previous day, and 2mL of venous blood was taken on an empty stomach in the morning of the next day. They ate the tested food (containing about 25g or 10g carbohydrates, as shown in Table 2 and 3) on different dates respectively. The eating methods were as follows: The upgraded sample of grain fiber powder formula was washed and adjusted with 1:8 times of warm water at 60-70℃, stirred for about 2min and turned into a slightly thickened state, then put it at the palatability temperature and drink it. The perfect nutrition meal is rinsed with 1:6 times hot water at about 70℃, stirred evenly for about 1min, and then put it to the palatability temperature for drinking; Zhen Shu cereal bar pastry ready to eat in open bag; The nutritious meal + compound dietary fiber powder (good mixing according to the ratio of 1:1) is rinsed at 1:6 times in hot water around 70℃, stirred evenly for about 1min, and then put it to the palatability temperature for drinking; 17 light drink ferment drink directly after opening the bag. Venous blood was taken at 15, 30, 45, 60, 90 and 120 minutes, and blood glucose was measured within 3 hours. The blood collection method is the same as the above glucose test.

(3) Determination of plasma glucose: hexokinase method, with Beckman 5800 series automatic biochemical analyzer and its reagent determination.

(4) Calculation of food GI: With glucose as the reference (GI=100), the internationally used Wolever method was used to calculate food GI, with time as abscissa and blood sugar value at each time point as ordinate Postprandial glucose response curve. The elevated glucose area (AUC) under the glucose curve was calculated geometrically, and the food GI and 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.

(5) Quality control: (1) Formulate unified operation implementation methods and evaluation standards to standardize the operation; (2) Laboratory inspection requirements: unified methods, instruments and reagents; ③ Draw blood by experienced nurse in charge to ensure that the drawing time and indwelling needle meet the requirements; (4) Statistical processing and analysis methods of data were determined and implemented by statistical experts. Blood glucose quality control charts were drawn. Unified maximum allowable line and warning limit values were set according to the target value, and the measurement results should be within the warning line. ⑤ Set up inspectors to supervise the quality of each special work; ⑥ This study was in compliance with ethical standards, approved by the Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University for filing, and informed consent signed by participating patients.

(VI) Data processing: The internationally used Wolever method was used to calculate the food GI. Using time as the abscissa and blood glucose values at each time point as the ordinate, the post-meal glucose response curves of the tested food were prepared and GI and GL were calculated.

Conditions
Glycemic Index
Being tested
Cereal powder, Pure glucose powder
Keywords
Glycemic Index, Glycemic Load

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cereal powderDietary supplement

    Also called perfect meals, 17 extraction enzyme

    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.

  • Pure glucose powderDietary supplement

    Pure glucose powder

Study groups in NCT05143060
Study groupRoleWhat they receive
Cereal fiber powderExperimentalCereal fiber powder
Receives: Dietary Supplement: Cereal powder
Pure glucose powderPlacebo comparatorPure glucose powder
Receives: Dietary Supplement: Pure glucose powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose

    Venous blood was collected up to 120 min

    Measured: Blood glucose was measured within 3 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start1 Apr 2021
  3. Primary completion10 Nov 2021
  4. Study completion10 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05143060
Sponsor's protocol ID
SYSEC-KY-KS-2020-203
Status last verified
Nov 2021
First submitted
22 Nov 2021
Last updated
3 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 6259925
  • 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.

    PubMed 19737630
  • 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.

    PubMed 18326601

Questions about this trial

What is this clinical trial studying?

A study testing Cereal powder and Pure glucose powder in people with Glycemic Index, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose (time frame: Blood glucose was measured within 3 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143060, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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