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Table 1 Summary of outcome measures

From: Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and β-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis

Outcomes

Time point

Measurement

Primary outcome

 HbA1c

At 6 months

Measured from whole blood from K2EDTA tube on a Cobas c 311, Roche Diagnostics, Auckland, New Zealand

Secondary outcomes

 HbA1c

At 3 and 9 months

Measured from whole blood from K2EDTA tube on a Cobas c 311, Roche Diagnostics, Auckland, New Zealand

 Fasting plasma glucose

At 3, 6, and 9 months

Measured from plasma from fluoride/oxalate tube on a Cobas c 311, Roche Diagnostics, Auckland, New Zealand

 Fasting insulin

Measured from plasma from K2EDTA by Human/Canine/Porcine Insulin DuoSet ELISA R&D Systems Inc.

 HOMA-IR

Calculated as HOMA = (glucose (mmol/l) x insulin (pmol/l))/22.5 [43]

 Fasting lipid profiles

Measured from fasting serum from SST II Advance Tube as total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides. Measured on a Cobas c 311, Roche Diagnostics, Auckland, New Zealand

 Blood pressure

At 3 and 6 months

Measured as mean systolic and mean diastolic blood pressure using standard calibrated electronic sphygmomanometer and protocol*

 Weight

Measured in kg using standard calibrated electronic equipment and protocol*

 Waist circumference

Measured in cm using standard equipment and protocol*

 Body mass index

Calculated as weight (kg)/height (m)2

 Depression, anxiety, and stress scores

At 6 and 9 months

Measured using DASS 21. The DASS is a set of three self-report scales designed to measure states of depression, anxiety and stress. It has validated psychometric properties, with good test–retest properties in both clinical and community populations, and is robust across a range of demographic variables [44,45,46,47,48]

 Physical and emotional well-being

Measured using SF-36. The SF-36 is a self-completed questionnaire, relating to physical and emotional health over the past 4 weeks. It is a well-validated scale, with good psychometric properties, widely used as a health outcome measure [42, 49,50,51]. Raw data will be uploaded and analysed on the ‘QualityMetric Health Outcomes TM scoring software 5.1. Permission to use granted on 13 December 2017

Other outcomes

 Adverse events

At 3, 6, and 9 months

Hospitalizations

Gastrointestinal symptoms and bowel function

 Compliance

At 3 and 6 months

Calculated based on return of unused cereal and capsules

  1. *See Additional file 2 for equipment and protocols for anthropometric and blood pressure measures
  2. DASS 21 Shortened version of the Depression Anxiety Stress Scale, HbA1c glycated haemoglobin, HOMA-IR homeostatic model assessment of insulin resistance, SF-36 Short-form health survey version 2 for New Zealand/Australia
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Trials

ISSN: 1745-6215