Type 2 DiabetesNCT05145673
Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus
A study testing Cinnamon (OGTT plus aqueous cinnamon extract) in people with Type 2 Diabetes, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.
Trial summary
The type 2 diabetes mellitus is a chronic disease and it is a highly prevalent globally. Cinnamon is a spicy used on the traditional cuisine, which have as been associated with beneficial effects on postprandial blood glucose levels (BGL). Read more about this study
- Who is it for?
- Ages 35 to 77 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cinnamon (OGTT plus aqueous cinnamon extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2016to 31 Oct 2016
- 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 35 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects aged 18 years or older
- subjects with DM2 diagnostic and men or non-pregnant women.
Who cannot join
- insulin-treated subjects
- history of gastrointestinal symptoms/diseases
- allergy to cinnamon
- fasting less than 8 hours
- cinnamon intake at day before the intervention
- intense exercise until 2 hours before the intervention
About this study
Official title: Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
The type 2 diabetes mellitus is a chronic disease and it is a highly prevalent globally. Cinnamon is a spicy used on the traditional cuisine, which have as been associated with beneficial effects on postprandial blood glucose levels (BGL). The aim of the present study was to investigate the effect of cinnamon tea (6g C. burmannii/100mL) on postprandial glycaemia in type 2 diabetic adults.
Following ethical committee approval, thirty-six subjects were selected and randomly allocated in 2 groups (n=18): cinnamon group, which was administrated OGTT (oral glucose tolerance test) followed by cinnamon tea; control group, which was administrated only OGTT. At baseline, anthropometric data, medical condition and pharmacological therapy were collected. A 24-hour dietary recall was taken preceding each intervention. Food Processor SQL (version 10.5.9) program was used to analyze the food nutritional composition. Chemical analysis was performed for total phenols determinations (adapted from Prabha et al) and antioxidant activity for FRAP and for DPPH tests (adapted from K. Thaipong et al.) Statistical analysis was performed using SPSS Statistics program. Data are mean±SEM.
Read the detailed description
Type 2 diabetes mellitus (DM2) subjects aged between 35-77 years were recruited into this study through nutrition appointment, Holon Pharmacy from Lisbon and Portalegre, Portugal. After the approval of the Ethics Committee, 36 individuals, were selected and invited to participate in this study. After eligibility criteria applied, a randomized controlled clinical trial, blind to participants, was conducted to 36 DM2 subjects. Participants were randomly assigned to intervention (n=18) or control group (n=18). The first participant of the study was randomly allocated to intervention or control group and the following participants were systematically allocated in each group. The anonymity and the confidentiality of the participants data collected were guaranteed through a code attributed to each participant. The control group was given a glucose solution to oral glucose tolerance test (OGTT) and the intervention group was given a glucose solution to OGTT followed by a cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.
Aqueous cinnamon extract was prepared by Cinnamomum burmannii bark (from Sucrame Company, Portugal) with Indonesia origin. Sticks of cinnamon (60 g) were soaked into 1000 mL of water. After 24 h at room temperature, cinnamon solution was heated for 30 min at 100°C and then filtered at room temperature. After the cinnamon tea preparation a 100 mL individual dose was distributed to each participant. For chemical analysis, a hydromethanolic extract (50 : 50) was performed with aqueous cinnamon extract previously obtained.
Anthropometric paraments and pharmacological therapy data were collected at the beginning of the study. At day before the intervention, a 24-hour food recall questionnaire was employed to participants of the study and carefully instructed by an investigator to complete the food record. The Food Processor SQL (10.14.2. version) programme was applied to analysed the nutritional composition of meals, such as, total energy intake (Kcal), proteins (g), lipids (g), carbohydrates (g), dietary fibre (g) and soluble fibre (g). It were also estimated the glycemic index and glycemic load of food intake.
Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0). Maximum concentrations (Cmax) and variations of maximum concentrations (ΔCmax) were determined by comparing with its respective baseline glycemia levels values.
The total phenolic concentration in the C. burmanni extract was determined according to Folin-Ciocalteu method employing gallic acid as standard. For the determination of antioxidant activity two methods were performed: FRAP and DPPH, adapted by Thaipong et al. The FRAP method for determination of ferric reducing effect was based on the reduction, at low pH, employing a colourless ferric complex (Fe3+) to a blue-coloured ferrous complex (Fe2+) by electron-donating antioxidants action in 2,4,6-tri(2-pyridyl)-s-triazine (TPTZ) presence.
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo (OGTT), Cinnamon (OGTT plus aqueous cinnamon extract)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (OGTT)Other
The control group was given an glucose solution to oral glucose tolerance test (OGTT) The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.
Cinnamon (OGTT plus aqueous cinnamon extract)Other
The intervention group was given an glucose solution to OGTT followed by a cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (OGTT) | Placebo comparator | The control group was given an glucose solution to oral glucose tolerance test (OGTT) . Receives: Other: Placebo (OGTT) |
| Cinnamon (OGTT plus aqueous cinnamon extract) | Experimental | The Experimental group was given an glucose solution to oral glucose tolerance test (OGTT) followed by aqueous cinnamon extract. Receives: Other: Cinnamon (OGTT plus aqueous cinnamon extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels at beginning
Mean values of blood glucose levels from both control and experimental groups
Measured: At beginning (before intervention)
Blood glucose levels at 30 minutes
Mean values of blood glucose levels from both control and experimental groups
Measured: At 30 minutes after intervention
Blood glucose levels at 60 minutes
Mean values of blood glucose levels from both control and experimental groups
Measured: At 60 minutes after intervention
Blood glucose levels at 90 minutes
Mean values of blood glucose levels from both control and experimental groups
Measured: At 90 minutes after intervention
Blood glucose levels at 120 minutes
Mean values of blood glucose levels from both control and experimental groups
Measured: At 120 minutes after intervention
Incremental area under the curve of blood glucose
Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0)
Measured: At 120 minutes after intervention
Variation of blood glucose maximum concentration
Mean values of glucose maximum concentration variation
Measured: At 60 minutes after intervention
Secondary outcomes (13)
Anthropometric parameters - body weight
Mean values of body weight (in kilogram - Kg)
Measured: At baseline
Anthropometric parameters - height
Mean values of Height (in centimeters - cm)
Measured: At baseline
Anthropometric parameters - waist circumference
Mean values of waist circumference (in centimeters - cm)
Measured: At baseline
Anthropometric parameters - body mass index
Mean values of body mass index (Kg/m2), calculated as weight (Kg) divided by height (m2) squared (Kg/m2)
Measured: At baseline
Anthropometric parameters - Skeletal muscle mass
Mean values of Skeletal muscle mass (in kilogram - Kg)
Measured: At baseline
Anthropometric parameters - visceral fat
Mean values of visceral fat (cm3)
Measured: At baseline
Pharmacological therapy
Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors
Measured: At baseline
Total protein intake
Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software
Measured: At baseline
Total lipid intake
Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software
Measured: At baseline
Total carbohydrate intake
Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software
Measured: At baseline
Total energy intake
Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software
Measured: At baseline
Total polyphenols content
Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid)
Measured: At baseline
Antioxidant activity
Mean values of antioxidant activity of cinnamon extract by FRAP and DPPH assays (micromol Trolox/L)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start19 Jan 2016
- Primary completion3 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145673
- Sponsor's protocol ID
- 525cinnamon
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05145673
- Acronym / sponsor ID
- 525cinnamon
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 3 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 6 Dec 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.
The type 2 diabetes mellitus is a chronic disease and it is a highly prevalent globally. Cinnamon is a spicy used on the traditional cuisine, which have as been associated with beneficial effects on postprandial blood glucose levels (BGL). The aim of the present study was to investigate the effect of cinnamon tea (6g C. burmannii/100mL) on postprandial glycaemia in type 2 diabetic adults.
Following ethical committee approval, thirty-six subjects were selected and randomly allocated in 2 groups (n=18): cinnamon group, which was administrated OGTT (oral glucose tolerance test) followed by cinnamon tea; control group, which was administrated only OGTT. At baseline, anthropometric data, medical condition and pharmacological therapy were collected. A 24-hour dietary recall was taken preceding each intervention. Food Processor SQL (version 10.5.9) program was used to analyze the food nutritional composition. Chemical analysis was performed for total phenols determinations (adapted from Prabha et al) and antioxidant activity for FRAP and for DPPH tests (adapted from K. Thaipong et al.) Statistical analysis was performed using SPSS Statistics program. Data are mean±SEM.
Detailed description
Type 2 diabetes mellitus (DM2) subjects aged between 35-77 years were recruited into this study through nutrition appointment, Holon Pharmacy from Lisbon and Portalegre, Portugal. After the approval of the Ethics Committee, 36 individuals, were selected and invited to participate in this study. After eligibility criteria applied, a randomized controlled clinical trial, blind to participants, was conducted to 36 DM2 subjects. Participants were randomly assigned to intervention (n=18) or control group (n=18). The first participant of the study was randomly allocated to intervention or control group and the following participants were systematically allocated in each group. The anonymity and the confidentiality of the participants data collected were guaranteed through a code attributed to each participant. The control group was given a glucose solution to oral glucose tolerance test (OGTT) and the intervention group was given a glucose solution to OGTT followed by a cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups.
Aqueous cinnamon extract was prepared by Cinnamomum burmannii bark (from Sucrame Company, Portugal) with Indonesia origin. Sticks of cinnamon (60 g) were soaked into 1000 mL of water. After 24 h at room temperature, cinnamon solution was heated for 30 min at 100°C and then filtered at room temperature. After the cinnamon tea preparation a 100 mL individual dose was distributed to each participant. For chemical analysis, a hydromethanolic extract (50 : 50) was performed with aqueous cinnamon extract previously obtained.
Anthropometric paraments and pharmacological therapy data were collected at the beginning of the study. At day before the intervention, a 24-hour food recall questionnaire was employed to participants of the study and carefully instructed by an investigator to complete the food record. The Food Processor SQL (10.14.2. version) programme was applied to analysed the nutritional composition of meals, such as, total energy intake (Kcal), proteins (g), lipids (g), carbohydrates (g), dietary fibre (g) and soluble fibre (g). It were also estimated the glycemic index and glycemic load of food intake.
Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0). Maximum concentrations (Cmax) and variations of maximum concentrations (ΔCmax) were determined by comparing with its respective baseline glycemia levels values.
The total phenolic concentration in the C. burmanni extract was determined according to Folin-Ciocalteu method employing gallic acid as standard. For the determination of antioxidant activity two methods were performed: FRAP and DPPH, adapted by Thaipong et al. The FRAP method for determination of ferric reducing effect was based on the reduction, at low pH, employing a colourless ferric complex (Fe3+) to a blue-coloured ferrous complex (Fe2+) by electron-donating antioxidants action in 2,4,6-tri(2-pyridyl)-s-triazine (TPTZ) presence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (OGTT) | Placebo comparator | Other: Placebo (OGTT)The control group was given an glucose solution to oral glucose tolerance test (OGTT) . |
| Cinnamon (OGTT plus aqueous cinnamon extract) | Experimental | Other: Cinnamon (OGTT plus aqueous cinnamon extract)The Experimental group was given an glucose solution to oral glucose tolerance test (OGTT) followed by aqueous cinnamon extract. |
Who may qualify
- Ages
- 35 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects aged 18 years or older
- subjects with DM2 diagnostic and men or non-pregnant women.
Key exclusion criteria (6 listed)
- insulin-treated subjects
- history of gastrointestinal symptoms/diseases
- allergy to cinnamon
- fasting less than 8 hours
- cinnamon intake at day before the intervention
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 |
|---|---|---|
| Placebo (OGTT)The control group was given an glucose solution to oral glucose tolerance test (OGTT) The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups. | Other | Placebo (OGTT) |
| Cinnamon (OGTT plus aqueous cinnamon extract)The intervention group was given an glucose solution to OGTT followed by a cinnamon aqueous extract. The glucose solution consist in a glucose drink with 75g of anhydrous D-Glucose dissolved in 200 mL of water at room temperature, as prescribed by ADA. The blood glucose levels were measured before intervention at fasting (t0) and after 30 (t30), 60 (t60, 90 (t90) and 120 (t120) minutes after intervention from both groups. | Other | Cinnamon (OGTT plus aqueous cinnamon extract) |
Primary outcome
Blood glucose levels at beginning
Time frame: At beginning (before intervention)
Mean values of blood glucose levels from both control and experimental groups
Blood glucose levels at 30 minutes
Time frame: At 30 minutes after intervention
Mean values of blood glucose levels from both control and experimental groups
Blood glucose levels at 60 minutes
Time frame: At 60 minutes after intervention
Mean values of blood glucose levels from both control and experimental groups
Blood glucose levels at 90 minutes
Time frame: At 90 minutes after intervention
Mean values of blood glucose levels from both control and experimental groups
Blood glucose levels at 120 minutes
Time frame: At 120 minutes after intervention
Mean values of blood glucose levels from both control and experimental groups
Incremental area under the curve of blood glucose
Time frame: At 120 minutes after intervention
Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0)
Variation of blood glucose maximum concentration
Time frame: At 60 minutes after intervention
Mean values of glucose maximum concentration variation
13 secondary outcomes
Anthropometric parameters - body weight
Time frame: At baseline
Anthropometric parameters - height
Time frame: At baseline
Anthropometric parameters - waist circumference
Time frame: At baseline
Anthropometric parameters - body mass index
Time frame: At baseline
Anthropometric parameters - Skeletal muscle mass
Time frame: At baseline
Anthropometric parameters - visceral fat
Time frame: At baseline
Pharmacological therapy
Time frame: At baseline
Total protein intake
Time frame: At baseline
Total lipid intake
Time frame: At baseline
Total carbohydrate intake
Time frame: At baseline
Total energy intake
Time frame: At baseline
Total polyphenols content
Time frame: At baseline
Antioxidant activity
Time frame: At baseline
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 6 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon (OGTT plus aqueous cinnamon extract) in people with Type 2 Diabetes, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.
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 2 inclusion and 6 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 levels at beginning (time frame: At beginning (before intervention)). The study lists 7 primary outcomes in all. 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 6 Dec 2021.