HealthyNCT05804942
Metabolic Response to Variations in Dietary Glycemic Index
A study testing High glycemic index, Medium glycemic index and Low glycemic index in people with Healthy and Hunger, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
The goal of this study is to compare metabolic response to variations in dietary glycemic index in healthy participants. The main questions it aims to answer are: What are the metabolic hunger and food intake responses to different levels of glycemic index on the background of otherwise constant macronutrient… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hunger, Food Preferences
- What is being tested?
- High glycemic index, Medium glycemic index and Low glycemic index
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2023to 1 Jun 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (both men and women)
- 18-40 years old
- 18.5 ≤ BMI (body mass index)<24 kg/m2
Who cannot join
- Those who have undergone surgery in the past 6 months.
- People are requiring long-term medication.
- People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
- Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
- People are losing weight by tablets.
- People are suffering from infectious diseases (e.g. HIV, etc.)
Show all 10Show fewer
- People have blood phobia, pathological hypo or hyper tension.
- People with impaired glucose tolerance.
- Pregnant and lactation women.
- Those who are afflicted with claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to compare metabolic response to variations in dietary glycemic index in healthy participants. The main questions it aims to answer are:
- What are the metabolic hunger and food intake responses to different levels of glycemic index on the background of otherwise constant macronutrient composition? Participants will come to the lab after an overnight fast and body composition will be tested by bio-impedance analysis and magnetic resonance imaging. They will then be randomized to eat one of three standardized breakfasts varying in the glycemic index. Circulating glucose levels will be monitored using a continuous glucose monitor and blood samples will be collected to measure metabolic and hormone factors in the serum. Participants will also rate their hunger at 0, 30, 60, 120, 180, 240 and 300 minutes. After 5 hours they will eat a free choice meal from a standardized selection buffet (test meal).
Read the detailed description
The primary variable in this study is the food energy intake at the test meal consumed 5 hours after the dietary intervention meal on day1 of the experiment, compared to the intake of the same test meal consumed on day 0. The investigators performed a power analysis using this outcome measure to inform the sample size if the data were analysed using one-way ANOVA. The number of levels in the study is 3, the investigators set the effect size as a difference between means of the groups of 265 kJ. From a pilot study of repeated measurements across individuals the investigators observed the standard deviation of the difference between repeated intakes was 372 kJ. The investigators set the power value of the study at 80 %. This analysis suggested a sample of 39 individuals per group. To account for individuals potentially not completing the study, the investigators aimed to recruit 135 participants in total.
The experiment includes the pre-test, the dietary intervention and postprandial monitoring.
Pre-test. The participants will be fed a test meal (free choice from buffet) at noon the day before the experiment (day 0). The food preference and total energy intake will be assessed. On the experimental day (day 1), the participants will be asked to attend the laboratory in the morning after an overnight fast (10 hours fasting). The body composition will be measured using a bio-impedance and magnetic resonance imaging, Then the participants will be guided to wear a continuous glucose monitoring system (CGMS) and the CGMS is under initialization for 2 hours. Also, a peripheral venous catheter (PVC) will be placed in the back of the hand, upper arm or elbow socket and 6 ml of fasting peripheral blood will be drawn (0 min).
Dietary intervention. 60 male and 60 female participants will be randomly divided into three groups: low, moderate and high glycemic index groups. Each group consists of 20 males and females. They will be feed by standardized meal with constant fat, protein and carbohydrate % but differing in the source of the carbohydrates.
Postprandial test. The test includes the testing of physiological indices during and after the intervention meal. In addition to continuously recording the changes in blood glucose by CGMS, the hunger rate will be accessed at 30 minutes intervals and peripheral blood will be collected by PVC (6 ml each time) at 30, 60, 120, 180, 240 and 300 min after the meal. When the participants have finished the tests during 300 min, a test meal will be provided identical to that provided on day 0. The effect of the standard meal on the total energy intake and macronutrient (carbohydrate, protein, fat) supply will be accessed in absolute amounts and the change between day 0 and day 1.
- Conditions
- Healthy, Hunger, Food Preferences
- Being tested
- High glycemic index, Medium glycemic index, Low glycemic index
- Keywords
- carbohydrate insulin model, circulating factors
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High glycemic indexBehavioural
Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:>70), 20% fat and 20% protein.
Medium glycemic indexBehavioural
Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:55-70), 20% fat and 20% protein.
Low glycemic indexBehavioural
Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:<55), 20% fat and 20% protein.
| Study group | Role | What they receive |
|---|---|---|
| High glycemic index | Experimental | The participants will be fed a fixed calorie meal, which is high glycemic index with constant fat and protein. Receives: Behavioral: High glycemic index |
| Medium glycemic index | Experimental | The participants will be fed a fixed calorie meal, which is medium glycemic index with constant fat and protein. Receives: Behavioral: Medium glycemic index |
| Low glycemic index | Experimental | The participants will be fed a fixed calorie meal, which is low glycemic index with constant fat and protein. Receives: Behavioral: Low glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy intake of test meal between day 0 and day 1
The food intake will be assessed objectively by use of a feeding table. The test meal will be provided as lunch, and food types available on the table include staples, vegetables, mushrooms, meat, soy products, desserts, beverages and water. All types of food are unlimited. Food consumption will be recorded continuously by balances concealed under each food dish. The food energy density for each food will be measured by bomb calorimetry in kJ/g, and energy intake will be calculated as the product of the grams of each food eaten multiplied by the respective energy density and then summed, as kJ.
This test meal intake is measured on day 0 and then a repeat test meal measure is made under identical conditions on day 1. On day 1 an intervention meal is also consumed five hours before the test meal is consumed. On day 0 no such meal is consumed. The outcome measure is the change in food intake (kJ) between day 0 and day 1 reflecting the impact of the intervention meal.
Measured: Change in intake between day 0 and day 1
Secondary outcomes (4)
circulating hormones
Nurses will collect the blood samples on day 1. Levels of circulating hormones (insulin, leptin, glycogen,etc) in the serum will be measured by ELISA(Bio Tek, Synergy4) in mmol/L.
Measured: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
postprandial glucose
Standardized meal with different levels of glycemic index( low level: ≤ 55, moderate level: 55 < GI ≤ 70, high level: > 70) will be provided as breakfast on day 1. Independent of the GI, the energy supply ratio of macronutrients carbohydrate, protein and fat will be fixed at 60 %, 20 % and 20 % respectively. Glucose concentration after the standardized meal will be recorded by the continuous glucose monitoring system(Medtronic) in mmol/L during 5 hours.
Measured: fasting glucose and postprandial glucose for 5 hours
self reported hunger
Self reported hunger will be tested by rating scale question.
Measured: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
levels of circulating metabolic fuels
Nurses will collect the blood samples on day 1. Circulating lactate, free-fatty acids, triglycerides etc in mmol/L will be measured by ELISA(Bio Tek, Synergy4).
Measured: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start13 Apr 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804942
- Sponsor's protocol ID
- SIAT-IRB-221115-H0618
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Variations in Dietary Glycemic Index
- ClinicalTrials.gov ID
- NCT05804942
- Acronym / sponsor ID
- SIAT-IRB-221115-H0618
- Conditions
- Healthy, Hunger, Food Preferences
- Keywords
- carbohydrate insulin model, circulating factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare metabolic response to variations in dietary glycemic index in healthy participants. The main questions it aims to answer are:
- What are the metabolic hunger and food intake responses to different levels of glycemic index on the background of otherwise constant macronutrient composition? Participants will come to the lab after an overnight fast and body composition will be tested by bio-impedance analysis and magnetic resonance imaging. They will then be randomized to eat one of three standardized breakfasts varying in the glycemic index. Circulating glucose levels will be monitored using a continuous glucose monitor and blood samples will be collected to measure metabolic and hormone factors in the serum. Participants will also rate their hunger at 0, 30, 60, 120, 180, 240 and 300 minutes. After 5 hours they will eat a free choice meal from a standardized selection buffet (test meal).
Detailed description
The primary variable in this study is the food energy intake at the test meal consumed 5 hours after the dietary intervention meal on day1 of the experiment, compared to the intake of the same test meal consumed on day 0. The investigators performed a power analysis using this outcome measure to inform the sample size if the data were analysed using one-way ANOVA. The number of levels in the study is 3, the investigators set the effect size as a difference between means of the groups of 265 kJ. From a pilot study of repeated measurements across individuals the investigators observed the standard deviation of the difference between repeated intakes was 372 kJ. The investigators set the power value of the study at 80 %. This analysis suggested a sample of 39 individuals per group. To account for individuals potentially not completing the study, the investigators aimed to recruit 135 participants in total.
The experiment includes the pre-test, the dietary intervention and postprandial monitoring.
Pre-test. The participants will be fed a test meal (free choice from buffet) at noon the day before the experiment (day 0). The food preference and total energy intake will be assessed. On the experimental day (day 1), the participants will be asked to attend the laboratory in the morning after an overnight fast (10 hours fasting). The body composition will be measured using a bio-impedance and magnetic resonance imaging, Then the participants will be guided to wear a continuous glucose monitoring system (CGMS) and the CGMS is under initialization for 2 hours. Also, a peripheral venous catheter (PVC) will be placed in the back of the hand, upper arm or elbow socket and 6 ml of fasting peripheral blood will be drawn (0 min).
Dietary intervention. 60 male and 60 female participants will be randomly divided into three groups: low, moderate and high glycemic index groups. Each group consists of 20 males and females. They will be feed by standardized meal with constant fat, protein and carbohydrate % but differing in the source of the carbohydrates.
Postprandial test. The test includes the testing of physiological indices during and after the intervention meal. In addition to continuously recording the changes in blood glucose by CGMS, the hunger rate will be accessed at 30 minutes intervals and peripheral blood will be collected by PVC (6 ml each time) at 30, 60, 120, 180, 240 and 300 min after the meal. When the participants have finished the tests during 300 min, a test meal will be provided identical to that provided on day 0. The effect of the standard meal on the total energy intake and macronutrient (carbohydrate, protein, fat) supply will be accessed in absolute amounts and the change between day 0 and day 1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High glycemic index | Experimental | Behavioral: High glycemic indexThe participants will be fed a fixed calorie meal, which is high glycemic index with constant fat and protein. |
| Medium glycemic index | Experimental | Behavioral: Medium glycemic indexThe participants will be fed a fixed calorie meal, which is medium glycemic index with constant fat and protein. |
| Low glycemic index | Experimental | Behavioral: Low glycemic indexThe participants will be fed a fixed calorie meal, which is low glycemic index with constant fat and protein. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults (both men and women)
- 18-40 years old
- 18.5 ≤ BMI (body mass index)<24 kg/m2
Key exclusion criteria (10 listed)
- Those who have undergone surgery in the past 6 months.
- People are requiring long-term medication.
- People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
- Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
- People are losing weight by tablets.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High glycemic indexComposition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:>70), 20% fat and 20% protein. | Behavioural | High glycemic index |
| Medium glycemic indexComposition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:55-70), 20% fat and 20% protein. | Behavioural | Medium glycemic index |
| Low glycemic indexComposition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:<55), 20% fat and 20% protein. | Behavioural | Low glycemic index |
Primary outcome
Change in energy intake of test meal between day 0 and day 1
Time frame: Change in intake between day 0 and day 1
The food intake will be assessed objectively by use of a feeding table. The test meal will be provided as lunch, and food types available on the table include staples, vegetables, mushrooms, meat, soy products, desserts, beverages and water. All types of food are unlimited. Food consumption will be recorded continuously by balances concealed under each food dish. The food energy density for each food will be measured by bomb calorimetry in kJ/g, and energy intake will be calculated as the product of the grams of each food eaten multiplied by the respective energy density and then summed, as kJ. This test meal intake is measured on day 0 and then a repeat test meal measure is made under identical conditions on day 1. On day 1 an intervention meal is also consumed five hours before the test meal is consumed. On day 0 no such meal is consumed. The outcome measure is the change in food intake (kJ) between day 0 and day 1 reflecting the impact of the intervention meal.
4 secondary outcomes
circulating hormones
Time frame: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
postprandial glucose
Time frame: fasting glucose and postprandial glucose for 5 hours
self reported hunger
Time frame: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
levels of circulating metabolic fuels
Time frame: fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High glycemic index, Medium glycemic index and Low glycemic index in people with Healthy and Hunger, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences 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 3 inclusion and 10 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 28 Feb 2025. 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. 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?
Change in energy intake of test meal between day 0 and day 1 (time frame: Change in intake between day 0 and day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.