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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.

Completed

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

Official record
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Trial summary

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 groups in NCT05145673
Study groupRoleWhat they receive
Placebo (OGTT)Placebo comparatorThe control group was given an glucose solution to oral glucose tolerance test (OGTT) .
Receives: Other: Placebo (OGTT)
Cinnamon (OGTT plus aqueous cinnamon extract)ExperimentalThe 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.

  1. Blood glucose levels at beginning

    Mean values of blood glucose levels from both control and experimental groups

    Measured: At beginning (before intervention)

  2. Blood glucose levels at 30 minutes

    Mean values of blood glucose levels from both control and experimental groups

    Measured: At 30 minutes after intervention

  3. Blood glucose levels at 60 minutes

    Mean values of blood glucose levels from both control and experimental groups

    Measured: At 60 minutes after intervention

  4. Blood glucose levels at 90 minutes

    Mean values of blood glucose levels from both control and experimental groups

    Measured: At 90 minutes after intervention

  5. Blood glucose levels at 120 minutes

    Mean values of blood glucose levels from both control and experimental groups

    Measured: At 120 minutes after intervention

  6. 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

  7. Variation of blood glucose maximum concentration

    Mean values of glucose maximum concentration variation

    Measured: At 60 minutes after intervention

Secondary outcomes (13)
  1. Anthropometric parameters - body weight

    Mean values of body weight (in kilogram - Kg)

    Measured: At baseline

  2. Anthropometric parameters - height

    Mean values of Height (in centimeters - cm)

    Measured: At baseline

  3. Anthropometric parameters - waist circumference

    Mean values of waist circumference (in centimeters - cm)

    Measured: At baseline

  4. 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

  5. Anthropometric parameters - Skeletal muscle mass

    Mean values of Skeletal muscle mass (in kilogram - Kg)

    Measured: At baseline

  6. Anthropometric parameters - visceral fat

    Mean values of visceral fat (cm3)

    Measured: At baseline

  7. Pharmacological therapy

    Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors

    Measured: At baseline

  8. Total protein intake

    Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software

    Measured: At baseline

  9. Total lipid intake

    Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software

    Measured: At baseline

  10. Total carbohydrate intake

    Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software

    Measured: At baseline

  11. Total energy intake

    Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software

    Measured: At baseline

  12. Total polyphenols content

    Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid)

    Measured: At baseline

  13. 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.

  1. First posted6 Dec 2021
  2. Study start19 Jan 2016
  3. Primary completion3 Oct 2016
  4. Study completion31 Oct 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
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

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.

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Clinical Trial NCT05145673 | AzTrials