Cooper 1988.
| Study characteristics | ||
| Methods | Study design: cross‐over randomised controlled trial | |
| Participants |
Inclusion criteria: type 2 diabetes mellitus outpatients Exclusion criteria:
Diagnostic criteria: — Setting: outpatients Age group: adults and elderly people Sex: females and males Country where trial was performed: Australia |
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| Interventions |
Intervention(s): saccharin and starch 30 g daily Comparator(s): sucrose 28 g daily Duration of intervention: 6 weeks Duration of follow‐up: 6 weeks each dietary sequence Run‐in period: none Number of study centres: 1 |
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| Outcomes | Reported outcomes in full text of publication: HbA1c, body weight (kg), lipid profile (total‐C, HDL, LDL, TG), glucose levels (fasting), serum insulin | |
| Identification |
Trial identifier: — Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: commercial funding: grant from the Australian Sugar Industry in co‐operation with CSR and Millaquin Sugar Publication status: peer‐reviewed journal and full article |
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| Stated aim for study | Quote from publication: "The aim of this study was to compare both the short‐ and medium‐term metabolic effects of sucrose supplementation with those of saccharin and starch supplementation in non‐insulin‐dependent diabetic outpatients" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: insufficient information about the sequence generation process |
| Allocation concealment (selection bias) | Unclear risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence" Comment: insufficient information about the allocation concealment |
| Blinding of participants and personnel (performance bias) body weight | Low risk |
Quote from publication: "The usual diet of each patient was supplemented daily with either 28 g sucrose (sucrose diet) or saccharin and starch (saccharin diet). The saccharin and starch supplements were equivalent to about 28 g sucrose in sweetness and energy, respectively." Comment: placebos were described to be similar in taste (sweetness); investigator‐assessed outcome |
| Blinding of participants and personnel (performance bias) glucose levels | Low risk |
Quote from publication: "The usual diet of each patient was supplemented daily with either 28 g sucrose (sucrose diet) or saccharin and starch (saccharin diet). The saccharin and starch supplements were equivalent to about 28 g sucrose in sweetness and energy, respectively." Comment: placebos were described to be similar in taste (sweetness); fasting glucose; investigator‐assessed outcome |
| Blinding of participants and personnel (performance bias) HbA1c | Low risk |
Quote from publication: "The usual diet of each patient was supplemented daily with either 28 g sucrose (sucrose diet) or saccharin and starch (saccharin diet). The saccharin and starch supplements were equivalent to about 28 g sucrose in sweetness and energy, respectively." Comment: placebos were described to be similar in taste (sweetness); investigator‐assessed outcome |
| Blinding of participants and personnel (performance bias) insulin sensitivity/serum insulin | Low risk |
Quote from publication: "The usual diet of each patient was supplemented daily with either 28 g sucrose (sucrose diet) or saccharin and starch (saccharin diet). The saccharin and starch supplements were equivalent to about 28 g sucrose in sweetness and energy, respectively." Comment: placebos were described to be similar in taste (sweetness); investigator‐assessed outcome |
| Blinding of participants and personnel (performance bias) lipid profile | Low risk |
Quote from publication: "The usual diet of each patient was supplemented daily with either 28 g sucrose (sucrose diet) or saccharin and starch (saccharin diet). The saccharin and starch supplements were equivalent to about 28 g sucrose in sweetness and energy, respectively." Comment: placebos were described to be similar in taste (sweetness); investigator‐assessed outcome |
| Blinding of outcome assessment (detection bias) body weight | Unclear risk | Comment: the blinding of outcome assessors was not addressed; investigator‐assessed outcome |
| Blinding of outcome assessment (detection bias) glucose levels | Low risk | Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome |
| Blinding of outcome assessment (detection bias) HbA1c | Low risk | Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome |
| Blinding of outcome assessment (detection bias) insulin sensitivity/serum insulin | Low risk | Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome |
| Blinding of outcome assessment (detection bias) lipid profile | Low risk | Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome |
| Incomplete outcome data (attrition bias) body weight | Low risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: no missing outcome data; results for all 17 randomised participants were reported |
| Incomplete outcome data (attrition bias) glucose levels | Low risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: no missing outcome data; results for all 17 randomised participants were reported |
| Incomplete outcome data (attrition bias) HbA1c | Low risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: no missing outcome data; results for all 17 randomised participants were reported |
| Incomplete outcome data (attrition bias) insulin sensitivity/serum insulin | Low risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: no missing outcome data; results for all 17 randomised participants were reported |
| Incomplete outcome data (attrition bias) lipid profile | Low risk |
Quote from publication: "patients were randomly allocated to each 6‐week dietary sequence (11 sucrose diet first and 6 saccharin diet first)" Comment: no missing outcome data; results for all 17 randomised participants were reported |
| Selective reporting (reporting bias) | Low risk | Comment: the study protocol is unavailable, but the publication seems to include all expected outcomes (ORBIT classification) |
| Other bias | Unclear risk | Comment: cross‐over without washout period; industry funding |