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. 2020 May 25;2020(5):CD012885. doi: 10.1002/14651858.CD012885.pub2

Barriocanal 2008.

Study characteristics
Methods Study design: parallel randomised controlled trial
Participants Inclusion criteria
For group 1:

  • type 1 diabetes mellitus

  • male and female

  • 20 to 60 years old

  • diabetes duration of more than 5 years

  • normotensive or hypertensive under treatment

  • HbA1c of less than 10%

  • BMI between 20 and 35 kg/m²

  • without established renal disease


For group 2:

  • type 2 diabetes mellitus

  • male and female

  • 40 to 70 years old

  • diabetes onset at age greater than 30 years

  • diabetes duration of more than 1 year and less than 10 years

  • treated with diet and/or oral antidiabetic agents

  • normotensive or hypertensive under treatment

  • HbA1c of less than 10%

  • BMI between 25 and 35 kg/m²

  • without established renal disease


For group 3:

  • healthy participants

  • male and female

  • 20 to 60 years old

  • with normal or low‐normal BP (≤ 120/80 mmHg) in at least 2 measurements taken in different days

  • BMI between 20 and 35 kg/m²


Exclusion criteria

  • enrolment in a clinical trial of drugs within the last 3 months

  • significant cardiovascular, psychological, neurological, renal, or endocrine disease (apart from diabetes)

  • alcohol or drug abuse or acute illness

  • fasting glucose levels of less than 70 mg/dL or more than 200 mg/dL

  • BP ≥ 170/110 mmHg on the day of the experiment

  • HbA1c ≥ 10%

  • pregnancy

  • treatment with glucocorticoids and treatment with insulin (except for Group 1)


Diagnostic criteria: —
Setting: outpatients
Age group: adults and elderly people
Sex: females and males
Country where trial was performed: Paraguay
Interventions Intervention(s): steviol glycoside capsules (250 mg 3 times a day; purity of steviol glycosides was 92%)
Comparator(s): matching placebo
Duration of intervention: 3 months
Duration of follow‐up: 3 months
Run‐in period: none
Number of study centres: not reported (presumably 1)
Outcomes Reported outcomes in full text of publication: HbA1c, body weight (kg), adverse events, anthropometric measures other than body weight (kg), lipid profile (total‐C, HDL, LDL, TG), glucose levels (fasting), serum insulin
Identification Trial identifier: —
Trial terminated early: no
Publication details Language of publication: English
Funding: commercial funding: Steviafarma Industrial S.A., Maringa, Brazil and non‐commercial funding: Ministry of Agriculture of Paraguay and the Banco Interamericano de Desarrollo (Interamerican Development Bank)
Publication status: peer‐reviewed journal and full article
Stated aim for study Quote from publication: "The aim of this study was to investigate the effect of steviol glycosides consumption in humans (both diabetics ‐ Type 1 and Type 2 ‐ and non‐diabetics with normal/low‐normal blood pressure) in order to comply with the first part (the pharmacological effects of steviol glycosides in humans) of the Annex 2 of the 63rd meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "Volunteers were randomly assigned to receive either steviol glycoside capsules 250 mg t.d.i. or matching placebo"
Comment: no information about the sequence generation process
Allocation concealment (selection bias) Unclear risk Quote from publication: "Volunteers were randomly assigned to receive either steviol glycoside capsules 250 mg t.d.i. or matching placebo"
Comment: no information about allocation concealment
Blinding of participants and personnel (performance bias)
adverse events Low risk Quote from publication: "matching placebo" was used
Comment: self‐reported outcome
Blinding of participants and personnel (performance bias)
anthropometric measures other than body weight Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of participants and personnel (performance bias)
body weight Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of participants and personnel (performance bias)
glucose levels Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of participants and personnel (performance bias)
HbA1c Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of participants and personnel (performance bias)
insulin sensitivity/serum insulin Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of participants and personnel (performance bias)
lipid profile Low risk Quote from publication: "matching placebo" was used
Comment: investigator‐assessed outcome
Blinding of outcome assessment (detection bias)
adverse events Low risk Comment: participants (i.e. outcome assessors) were blinded; self‐reported outcome
Blinding of outcome assessment (detection bias)
anthropometric measures other than body weight Unclear risk Comment: no information about the blinding of outcome assessors
Blinding of outcome assessment (detection bias)
body weight Unclear risk Comment: no information about the blinding of outcome assessors
Blinding of outcome assessment (detection bias)
glucose levels Low risk Comment: no information about the blinding of outcome assessors; the outcome measurement is unlikely to have been influenced by potential lack of blinding
Blinding of outcome assessment (detection bias)
HbA1c Low risk Comment: no information about the blinding of outcome assessors; the outcome measurement is unlikely to have been influenced by potential lack of blinding
Blinding of outcome assessment (detection bias)
insulin sensitivity/serum insulin Low risk Comment: no information about the blinding of outcome assessors; the outcome measurement is unlikely to have been influenced by potential lack of blinding
Blinding of outcome assessment (detection bias)
lipid profile Low risk Comment: no information about the blinding of outcome assessors; the outcome measurement is unlikely to have been influenced by potential lack of blinding
Incomplete outcome data (attrition bias)
adverse events Low risk Quote from publication: "No drop‐outs were due to side effects"
Comment: no missing data for adverse events
Incomplete outcome data (attrition bias)
anthropometric measures other than body weight High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Incomplete outcome data (attrition bias)
body weight High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Incomplete outcome data (attrition bias)
glucose levels High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Incomplete outcome data (attrition bias)
HbA1c High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Incomplete outcome data (attrition bias)
insulin sensitivity/serum insulin High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Incomplete outcome data (attrition bias)
lipid profile High risk Quote from publication: "Eighty‐six volunteers (45 women, 41 men) were enrolled in the study and 76 completed it." "The study group consisted of 76 subjects (30 with Type 2 diabetes, 16 with Type 1 diabetes and 30 without diabetes" (Group 1: type 1 diabetes, Group 2: type 2 diabetes). "Ten volunteers (4 in Group 1, 3 in Group 2 and 3 in Group 3) decided to discontinue the study for no specific reason, but no due to side effects"
Comment: in total 20 participants with type 1 diabetes were randomised and 16 were analysed; in total 33 participants with type 2 diabetes were randomised and 30 analysed; reasons for attrition and balance of missing data across groups were not reported
Selective reporting (reporting bias) High risk Comment: described in the methods that weight and waist circumference were measured, but values were not reported
Other bias Unclear risk Comment: steviol glycoside capsules were supplied by the industry