Glucose MetabolismNCT04928872
Macronutrient Distribution and Plasma Metabolites to Model Meals Composition
An observational study of Glucose Metabolism, run by Texas A&M University at 1 site in United States.
Trial summary
Continuous glucose monitors (CGMs) measure plasma glucose concentration continually and thus they are a key tool in the management of diabetes, including type 2 diabetes (T2D). A key factor in diabetes management is a reduction of dietary carbohydrates (CHO) and/or exchanging high glycemic index (GI) CHO with low GI… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism
- What is being tested?
- Predefined meal
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 14 Jan 2020
- Phase
- Observational
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older adults (60-85y; equal gender) with a BMI between 25 and 35 will be recruited from an existing database of CTRAL. In addition, we will recruit older adults that respond to distributed flyers and advertisements in the newspaper and to radio announcements in the community of the College Station/Bryan area. Informed consent will be obtained on the screening day before any study-related procedures will be performed. If inclusion/exclusion criteria are met, subjects are invited to take part in the study.
Who may be able to join
- Ability to walk, sit down and stand up independently
- Ability to lie in a supine or slightly elevated position for 8.5 hours
- BMI between 25 and 35 kg/m2
- Willingness and ability to comply with the protocol
Who cannot join
- Established diagnosis of malignancy
- Established diagnosis of Insulin-Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Recent myocardial infarction (less than 1 year)
- Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation Between the Meal Macronutrient Distribution and Plasma Metabolites to Model the Composition of Meals of Patients With Diabetes II and Cardiovascular Disease.
Continuous glucose monitors (CGMs) measure plasma glucose concentration continually and thus they are a key tool in the management of diabetes, including type 2 diabetes (T2D). A key factor in diabetes management is a reduction of dietary carbohydrates (CHO) and/or exchanging high glycemic index (GI) CHO with low GI CHO. However, the protein and fat content of the meal can have a significant impact on the glucose readings obtained from a CGM as there is no enough data available on their sensitivity during meals.
Read the detailed description
The study involves 1 screening visit of approximately 1 hour and 9 study days of approximately 8 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.
To test the relation between plasma amino acid, triglycerides, and glucose concentration measured by standard methods (such as finger stick) and continuous wearable devices, a premarket FDA-approved continuous glucose monitor (CGM) from Abbott (FreeStyle Libre Pro) that monitors glucose concentrations every 15 min is used. The single-use sensors are placed on the upper arm and contain a very tiny 5 mm filament (<0.4 mm diameter) that is introduced into the skin when the sensor is placed. On the first study day, the CGM will be placed to monitor glucose concentrations until the last study day. At least every 14 days, sensors will be replaced by new ones. On each study day, body weight and height will be measured and the glucose concentration data will be downloaded from the sensor onto the reader device. A catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn at times: 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, and 480 minutes (13 blood samples, total blood approx 65 ml). Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including fatty acids, glucose, insulin).
- Conditions
- Glucose Metabolism
- Being tested
- Predefined meal
- Keywords
- response to food, plasma glucose, continuous glucose monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predefined mealCombination product
Nine predefined meals are administered in a randomized fashion, one meal per one study day, 2-3 study days per week. Meals have a form of drinks with different compositions of protein, carbohydrates and fat in relation to the US diet
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic older adults | Non-diabetic older adults Receives: Combination Product: Predefined meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma concentrations of amino acids, glucose, and/or triglycerides
Participants consume 9 predefined meals in the fasted state with macronutrient composition reflecting common meals in the US diet. One meal is consumed during one study visit with a total of 9 visits. A baseline sample is collected followed by an intake of one meal during one study visit. Blood samples (in the 15-and 30-minutes interval) are collected for 8 hours after a meal intake. Collected plasma will be used for amino acid analysis. Statistical models will be used to predict plasma amino acids from patterns of amino acids, glucose, and/or triglycerides in the consumed meals.
Measured: 9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.
Secondary outcomes (1)
Discordance of glucose measurement after an intake of the predefined meal as measured by a fingerstick, continuous glucose monitor, and certified laboratory
A continuous glucose monitor is placed during the first study visit. Participants consume 9 predefined meals in the fasted state with macronutrient composition reflecting common meals in the US diet. One meal is consumed during one study visit. A baseline sample is collected followed by an intake of one meal during one study visit. Blood samples (in the 15-and 30-minutes interval) for glucose measurements are taken and plasma samples are collected. Plasma glucose is measured by a glucose monitor and outsourced to the certified laboratory. Information from continuous glucose monitor is collected at the end of each study day.
Measured: 9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start20 Jun 2018
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Nicolaas EP Deutz, MD, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928872
- Sponsor's protocol ID
- 2017-0886
- Status last verified
- Feb 2022
- First submitted
- 1 Jun 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
PubMed 39423760Barua S, A Wierzchowska-McNew R, Deutz NEP, Sabharwal A. Discordance between postprandial plasma glucose measurement and continuous glucose monitoring. Am J Clin Nutr. 2022 Oct 6;116(4):1059-1069. doi: 10.1093/ajcn/nqac181.
PubMed 35776949
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between the Meal Macronutrient Distribution and Plasma Metabolites to Model the Composition of Meals of Patients With Diabetes II and Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT04928872
- Acronym / sponsor ID
- 2017-0886
- Conditions
- Glucose Metabolism
- Keywords
- response to food, plasma glucose, continuous glucose monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 16 Jun 2021 (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.
Continuous glucose monitors (CGMs) measure plasma glucose concentration continually and thus they are a key tool in the management of diabetes, including type 2 diabetes (T2D). A key factor in diabetes management is a reduction of dietary carbohydrates (CHO) and/or exchanging high glycemic index (GI) CHO with low GI CHO. However, the protein and fat content of the meal can have a significant impact on the glucose readings obtained from a CGM as there is no enough data available on their sensitivity during meals.
Detailed description
The study involves 1 screening visit of approximately 1 hour and 9 study days of approximately 8 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.
To test the relation between plasma amino acid, triglycerides, and glucose concentration measured by standard methods (such as finger stick) and continuous wearable devices, a premarket FDA-approved continuous glucose monitor (CGM) from Abbott (FreeStyle Libre Pro) that monitors glucose concentrations every 15 min is used. The single-use sensors are placed on the upper arm and contain a very tiny 5 mm filament (<0.4 mm diameter) that is introduced into the skin when the sensor is placed. On the first study day, the CGM will be placed to monitor glucose concentrations until the last study day. At least every 14 days, sensors will be replaced by new ones. On each study day, body weight and height will be measured and the glucose concentration data will be downloaded from the sensor onto the reader device. A catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn at times: 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, and 480 minutes (13 blood samples, total blood approx 65 ml). Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including fatty acids, glucose, insulin).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic older adults | – | Combination Product: Predefined mealNon-diabetic older adults |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older adults (60-85y; equal gender) with a BMI between 25 and 35 will be recruited from an existing database of CTRAL. In addition, we will recruit older adults that respond to distributed flyers and advertisements in the newspaper and to radio announcements in the community of the College Station/Bryan area. Informed consent will be obtained on the screening day before any study-related procedures will be performed. If inclusion/exclusion criteria are met, subjects are invited to take part in the study.
Key inclusion criteria (4 listed)
- Ability to walk, sit down and stand up independently
- Ability to lie in a supine or slightly elevated position for 8.5 hours
- BMI between 25 and 35 kg/m2
- Willingness and ability to comply with the protocol
Key exclusion criteria (7 listed)
- Established diagnosis of malignancy
- Established diagnosis of Insulin-Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Recent myocardial infarction (less than 1 year)
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 |
|---|---|---|
| Predefined mealNine predefined meals are administered in a randomized fashion, one meal per one study day, 2-3 study days per week. Meals have a form of drinks with different compositions of protein, carbohydrates and fat in relation to the US diet | Combination product | Non-diabetic older adults |
Primary outcome
Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma concentrations of amino acids, glucose, and/or triglycerides
Time frame: 9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.
Participants consume 9 predefined meals in the fasted state with macronutrient composition reflecting common meals in the US diet. One meal is consumed during one study visit with a total of 9 visits. A baseline sample is collected followed by an intake of one meal during one study visit. Blood samples (in the 15-and 30-minutes interval) are collected for 8 hours after a meal intake. Collected plasma will be used for amino acid analysis. Statistical models will be used to predict plasma amino acids from patterns of amino acids, glucose, and/or triglycerides in the consumed meals.
1 secondary outcome
Discordance of glucose measurement after an intake of the predefined meal as measured by a fingerstick, continuous glucose monitor, and certified laboratory
Time frame: 9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.
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 21 Feb 2022.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Derived from this study: PubMed 39423760Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
- Derived from this study: PubMed 35776949Barua S, A Wierzchowska-McNew R, Deutz NEP, Sabharwal A. Discordance between postprandial plasma glucose measurement and continuous glucose monitoring. Am J Clin Nutr. 2022 Oct 6;116(4):1059-1069. doi: 10.1093/ajcn/nqac181.
- 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.
Nicolaas EP Deutz, MD, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism, run by Texas A&M University at 1 site in United States.
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 7 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 21 Feb 2022. 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 United States. 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?
Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma concentrations of amino acids, glucose, and/or triglycerides (time frame: 9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.). 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 NCT04928872, 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 21 Feb 2022.