Glucose, High BloodFP1NCT03972878
Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products
A study testing cream version 1, cream version 2 and cream version 3 in people with Glucose, High Blood and Inflammatory Response, run by University of Parma at 1 site in Italy.
Trial summary
The composition of a food or a meal consumed plays an important role in the rate of postprandial endocrine and metabolic response, especially if high in fats, sugars and total energy content and a reduction in its entity is related to beneficial effects towards the prevention of several chronical diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood, Inflammatory Response, Oxidative Stress
- What is being tested?
- cream version 1, cream version 2 and cream version 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2019to 31 Dec 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adult subjects
Who cannot join
- BMI > 30 kg/m2
- Metabolic disorders (diabetes, hypertension, dyslipidemia, glucidic intolerance)
- Chronic drug therapies for any pathologies (including psychiatric diseases)
- Dietary supplements affecting metabolism of glucose and lipid
- Celiac disease
- Pregnancy or lactation
- Lactose intolerance
- Food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
The composition of a food or a meal consumed plays an important role in the rate of postprandial endocrine and metabolic response, especially if high in fats, sugars and total energy content and a reduction in its entity is related to beneficial effects towards the prevention of several chronical diseases. The physiological postprandial response depends on several factors, both intrinsic, such as natural characteristic of food, and extrinsic, such as the way in which food is processed. This study aims at investigating postprandial hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses after the consumption of different commercial confectionary products made with different reformulation (ingredients and/or processing techniques).The principal scope of the study is to evaluate the impact of the reformulation of different snacks on postprandial responses. The investigators therefore designed a randomized controlled crossover trial, in which 15 healthy volunteers will consume different isocaloric confectionary products (snacks) and their related reformulation (total products number = 6) and a reference snack. Venous blood samples will be collected until 4-h after meal consumption. In order to evaluate postprandial hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses several markers will be evaluate:
- metabolic substrates: glucose; Triglycerides and NEFA;
- hormones: insulin; c-peptide; GLP-1, GIP, leptin, ghrelin, PYY;
- markers of inflammation: IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1;
- markers of oxidative stress and antioxidant capacity: GSH, FRAP;
- endotoxaemia: lipopolysaccharides (LPS).
These results will contribute to a detailed evaluation of the effects of reformulation on physiological events after meal consumption, leading to clarify if these variations in ingredients and/or processing techniques can modify postprandial responses, making them more similar to those originated from the reference snack.
Read the detailed description
Meal consumption, especially if high in fats, sugars and total energy content, leads to a transient rise in blood glucose and lipids. The extent of glycemic and lipidemic postprandial responses have been linked to the progression of cardiovascular and other chronic degenerative diseases, such as type 2 diabetes and Alzheimer through a substantial increase in oxidative stress, systemic inflammation, and endothelial dysfunction. In addition, some studies have shown that consuming a high fat meal is associated with a postprandial increase in plasma and serum endotoxin concentrations in humans. LPS, lipopolysaccharide, is considered a major predisposing factor for inflammation-associated diseases such as atherosclerosis, sepsis and obesity. Therefore, following a correct dietary model may be beneficial in order to limit postprandial excursion and to modulate hormonal responses involved in satiety.
The physiological postprandial response depends on several factors, both intrinsic, such as natural characteristic of food, and extrinsic, such as the way in which food is processed. Thus, the present study aims at evaluating if the reformulation of some commercial confectionery products can lead to an improvement of the nutritional profile, through a decrease of postprandial metabolic and hormonal, oxidative stress, inflammation and endotoxaemia responses in comparison with commercial confectionery products (snacks).
- Being tested
- control snack, control cream, cream version 1, cream version 2, cream version 3
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control snackOther
dry fruit snack (200 kcal) + 250 ml water
control creamOther
commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
cream version 1Other
commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
cream version 2Other
commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
cream version 3Other
commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
control chocolate barOther
commercial chocolate bar (200 kcal)+ 250 ml water
chocolate bar version 1Other
commercial chocolate bar (200 kcal), version 1+ 250 ml water
| Study group | Role | What they receive |
|---|---|---|
| control snack | Active comparator | control snack Receives: Other: control snack |
| control cream | Experimental | control spreadable cream Receives: Other: control cream |
| cream version 1 | Experimental | control spreadable cream, version 1 Receives: Other: cream version 1 |
| cream version 2 | Experimental | control spreadable cream, version 2 Receives: Other: cream version 2 |
| cream version 3 | Experimental | control spreadable cream, version 3 Receives: Other: cream version 3 |
| control chocolate bar | Experimental | control chocolate bar Receives: Other: control chocolate bar |
| chocolate bar version 1 | Experimental | control chocolate bar version 1 Receives: Other: chocolate bar version 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IAUC postprandial blood glucose
Incremental area under the curve of blood glucose postprandial response (IAUC)
Measured: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Secondary outcomes (11)
Postprandial response for blood glucose
incremental blood glucose concentration at each timepoint of the curve
Measured: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
Incremental area under the curve for blood insulin postprandial response (IAUC)
Measured: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
incremental blood insulin concentration at each timepoint of the curve
Measured: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Incremental area under the curve for blood TAG and NEFA postprandial response (IAUC)
Measured: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
incremental blood TAG and NEFA concentration at each timepoint of the curve
Measured: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Incremental area under the curve for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) postprandial response (IAUC)
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Incremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
incremental blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) concentration at each timepoint of the curve
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))
Incremental area under the curve for LPS
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood LPS
incremental blood LPS concentration at each timepoint of the curve
Measured: 0 (fasting), 60, 90, 120, 180, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start22 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Glucose, High BloodStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a cross-over, randomized intervention trial. Each subject consumed in a randomly order seven foods test with a one-week wash out between different treatments. The portion size of each foods test was calculated in order to provide the same calories.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Del Rio, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972878
- Sponsor's protocol ID
- FP-1.0
- Acronym
- FP1
- Status last verified
- Apr 2021
- First submitted
- 31 May 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Emerson SR, Kurti SP, Harms CA, Haub MD, Melgarejo T, Logan C, Rosenkranz SK. Magnitude and Timing of the Postprandial Inflammatory Response to a High-Fat Meal in Healthy Adults: A Systematic Review. Adv Nutr. 2017 Mar 15;8(2):213-225. doi: 10.3945/an.116.014431. Print 2017 Mar.
PubMed 28298267Erridge C, Attina T, Spickett CM, Webb DJ. A high-fat meal induces low-grade endotoxemia: evidence of a novel mechanism of postprandial inflammation. Am J Clin Nutr. 2007 Nov;86(5):1286-92. doi: 10.1093/ajcn/86.5.1286.
PubMed 17991637Herieka M, Erridge C. High-fat meal induced postprandial inflammation. Mol Nutr Food Res. 2014 Jan;58(1):136-46. doi: 10.1002/mnfr.201300104. Epub 2013 Jul 12.
PubMed 23847095O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.
PubMed 17719342Treib J, Haass A, Kiessig ST, Woessner R, Grauer MT, Schimrigk K. Tick-borne encephalitis diagnosis in patients with inflammatory changes in the cerebrospinal fluid in a region with very low prevalence. Infection. 1996 Sep-Oct;24(5):400-2. doi: 10.1007/BF01716095.
PubMed 8923057
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
- ClinicalTrials.gov ID
- NCT03972878
- Acronym / sponsor ID
- FP1 / FP-1.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Jun 2019 (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 composition of a food or a meal consumed plays an important role in the rate of postprandial endocrine and metabolic response, especially if high in fats, sugars and total energy content and a reduction in its entity is related to beneficial effects towards the prevention of several chronical diseases. The physiological postprandial response depends on several factors, both intrinsic, such as natural characteristic of food, and extrinsic, such as the way in which food is processed. This study aims at investigating postprandial hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses after the consumption of different commercial confectionary products made with different reformulation (ingredients and/or processing techniques).The principal scope of the study is to evaluate the impact of the reformulation of different snacks on postprandial responses. The investigators therefore designed a randomized controlled crossover trial, in which 15 healthy volunteers will consume different isocaloric confectionary products (snacks) and their related reformulation (total products number = 6) and a reference snack. Venous blood samples will be collected until 4-h after meal consumption. In order to evaluate postprandial hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses several markers will be evaluate:
- metabolic substrates: glucose; Triglycerides and NEFA;
- hormones: insulin; c-peptide; GLP-1, GIP, leptin, ghrelin, PYY;
- markers of inflammation: IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1;
- markers of oxidative stress and antioxidant capacity: GSH, FRAP;
- endotoxaemia: lipopolysaccharides (LPS).
These results will contribute to a detailed evaluation of the effects of reformulation on physiological events after meal consumption, leading to clarify if these variations in ingredients and/or processing techniques can modify postprandial responses, making them more similar to those originated from the reference snack.
Detailed description
Meal consumption, especially if high in fats, sugars and total energy content, leads to a transient rise in blood glucose and lipids. The extent of glycemic and lipidemic postprandial responses have been linked to the progression of cardiovascular and other chronic degenerative diseases, such as type 2 diabetes and Alzheimer through a substantial increase in oxidative stress, systemic inflammation, and endothelial dysfunction. In addition, some studies have shown that consuming a high fat meal is associated with a postprandial increase in plasma and serum endotoxin concentrations in humans. LPS, lipopolysaccharide, is considered a major predisposing factor for inflammation-associated diseases such as atherosclerosis, sepsis and obesity. Therefore, following a correct dietary model may be beneficial in order to limit postprandial excursion and to modulate hormonal responses involved in satiety.
The physiological postprandial response depends on several factors, both intrinsic, such as natural characteristic of food, and extrinsic, such as the way in which food is processed. Thus, the present study aims at evaluating if the reformulation of some commercial confectionery products can lead to an improvement of the nutritional profile, through a decrease of postprandial metabolic and hormonal, oxidative stress, inflammation and endotoxaemia responses in comparison with commercial confectionery products (snacks).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- The study is a cross-over, randomized intervention trial. Each subject consumed in a randomly order seven foods test with a one-week wash out between different treatments. The portion size of each foods test was calculated in order to provide the same calories.
| Arm | Type | Receives |
|---|---|---|
| control snack | Active comparator | Other: control snackcontrol snack |
| control cream | Experimental | Other: control creamcontrol spreadable cream |
| cream version 1 | Experimental | Other: cream version 1control spreadable cream, version 1 |
| cream version 2 | Experimental | Other: cream version 2control spreadable cream, version 2 |
| cream version 3 | Experimental | Other: cream version 3control spreadable cream, version 3 |
| control chocolate bar | Experimental | Other: control chocolate barcontrol chocolate bar |
| chocolate bar version 1 | Experimental | Other: chocolate bar version 1control chocolate bar version 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female adult subjects
Key exclusion criteria (8 listed)
- BMI > 30 kg/m2
- Metabolic disorders (diabetes, hypertension, dyslipidemia, glucidic intolerance)
- Chronic drug therapies for any pathologies (including psychiatric diseases)
- Dietary supplements affecting metabolism of glucose and lipid
- Celiac disease
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 |
|---|---|---|
| control snackdry fruit snack (200 kcal) + 250 ml water | Other | control snack |
| control creamcommercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water | Other | control cream |
| cream version 1commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water | Other | cream version 1 |
| cream version 2commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water | Other | cream version 2 |
| cream version 3commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water | Other | cream version 3 |
| control chocolate barcommercial chocolate bar (200 kcal)+ 250 ml water | Other | control chocolate bar |
| chocolate bar version 1commercial chocolate bar (200 kcal), version 1+ 250 ml water | Other | chocolate bar version 1 |
Primary outcome
IAUC postprandial blood glucose
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Incremental area under the curve of blood glucose postprandial response (IAUC)
11 secondary outcomes
Postprandial response for blood glucose
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood LPS
Time frame: 0 (fasting), 60, 90, 120, 180, 240 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 27 Apr 2021.
- Background: PubMed 28298267Emerson SR, Kurti SP, Harms CA, Haub MD, Melgarejo T, Logan C, Rosenkranz SK. Magnitude and Timing of the Postprandial Inflammatory Response to a High-Fat Meal in Healthy Adults: A Systematic Review. Adv Nutr. 2017 Mar 15;8(2):213-225. doi: 10.3945/an.116.014431. Print 2017 Mar.
- Background: PubMed 17991637Erridge C, Attina T, Spickett CM, Webb DJ. A high-fat meal induces low-grade endotoxemia: evidence of a novel mechanism of postprandial inflammation. Am J Clin Nutr. 2007 Nov;86(5):1286-92. doi: 10.1093/ajcn/86.5.1286.
- Background: PubMed 23847095Herieka M, Erridge C. High-fat meal induced postprandial inflammation. Mol Nutr Food Res. 2014 Jan;58(1):136-46. doi: 10.1002/mnfr.201300104. Epub 2013 Jul 12.
- Background: PubMed 17719342O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.
- Background: PubMed 8923057Treib J, Haass A, Kiessig ST, Woessner R, Grauer MT, Schimrigk K. Tick-borne encephalitis diagnosis in patients with inflammatory changes in the cerebrospinal fluid in a region with very low prevalence. Infection. 1996 Sep-Oct;24(5):400-2. doi: 10.1007/BF01716095.
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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 cream version 1, cream version 2 and cream version 3 in people with Glucose, High Blood and Inflammatory Response, run by University of Parma at 1 site in Italy.
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 1 inclusion and 8 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 27 Apr 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 Italy. 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?
IAUC postprandial blood glucose (time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes). 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 NCT03972878, which also lists 5 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 27 Apr 2021.