Effects of a protein ‘preload’ on glycaemia and gastric emptying over 4 weeks in patients with type 2 diabetes

A randomized, single-blind, cross-over trial to evaluate the effects of a protein ‘preload’ compared to placebo on glycaemia and gastric emptying over 4 weeks in patients with type 2 diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000831684

Enrollment

Registered

2014-08-05

Start date

2007-10-08

Completion date

2009-12-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients are randomised to receive 4 weeks treatments with a 25g whey protein 'preload' taken 30 min before each of the 3 main meals daily for 4 weeks, or placebo. After a 2 week 'washout' period, they cross over to the alternate treatment. They will attend the hospital for a test meal of radiolabelled mashed potato at the beginning and end of each intervention period, to evaluate whether the capacity of the protein preload to lower blood glucose concentrations and slow gastric emptying after the meal are sustained over 4 weeks.

Interventions

25g whey protein in a chocolate flavoured drink (or control) taken as a 'preload', 30 min before meals, three times daily, for 4 weeks. Adherence will be monitored by a daily diary with checkboxes to fill in on taking the preload, and by weekly telephone calls.There will be a 2 week 'washout' period before crossing over to the alternate intervention (control or whey protein).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

25 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients with type 2 diabetes managed by diet alone

Exclusion criteria

1. Significant medical disorders (other than diabetes); 2. Significant gastrointestinal symptoms or history of gastrointestinal surgery (other than appendicectomy or cholecystectomy); 3. Intake of >20 g alcohol on a daily basis or cigarette smoking; 4. Current use of medications which may affect gastrointestinal function or appetite (e.g. prokinetic drugs, orlistat, tricyclic antidepressants); 5. Current pregnancy or lactation; 6. Inability to prepare meals, or meet dietary requirements, (including frequent dining out (>2x/week)) and widely fluctuating exercise patterns; 7. Inability or unwillingness to perform capillary blood glucose monitoring; 8. Exposure to radiation as part of a research study in the preceding 12 months.

Outcome results