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| Name | Class |
|---|---|
| Newcastle University | OTHER |
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The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes.
The primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 75-90 years of age, living with type 2 diabetes, compared with a non-protein placebo.
Participants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.
Within the study, the researchers will look at the effect of supplemental whey protein at moderate and low doses in comparison to each other and a protein-free placebo on glycaemic control in older adults aged between 75-90 years of age, living with type 2 diabetes.
Glycaemic control (glucose excursions) will be monitored under free-living conditions over a 7-day period using continuous glucose monitors (CGMs). Participants will be randomised to consume one of the two whey protein doses as well as the protein-free placebo on a separate 7-day period. The order of consuming whey protein or the protein-free placebo will be randomised and counterbalanced. This study is under the evidence that in younger people living with type 2 diabetes, a moderate dose of whey protein improves glucose time in range and lessens extreme postprandial glucose excursions.
Participants will be free to consume their typical diet over this period, where the researchers will provide a diet diary for participants to enter in all foods and drinks they consume over this time period, as well as document the ingestion of the supplement before each main meal.
During an acute feeding period on the first ingestion of each supplement (start of each 7-day phase), the researchers will evaluate rates of gastric emptying, glucose and insulin concentrations and hormonal appetite markers through blood draws, as well as perceived appetite responses through visual analogue scales. This will be in a research kitchen where participants will consume the supplement and a controlled mixed meal afterwards to monitor excursions in appetite response and glycemia. The researchers will also investigate the impact of pre-meal protein feeding on renal markers following each 7-day phase via urine collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-meal low dose whey protein | Active Comparator | Low whey protein dose administration before meals |
|
| pre-meal moderate dose whey protein | Active Comparator | Moderate whey protein dose administration before meals |
|
| pre-meal protein-free placebo | Placebo Comparator | protein-free placebo administration before meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycaemic control with whey protein | Dietary Supplement | Comparing pre-meal supplementation of whey protein to protein-free placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of changes in free-living glycaemic control | Time spent in normal glucose range, under free-living conditions with pre-meal supplementation (measured by continuous glucose monitors) | 7 days, two occasions |
| Changes in postprandial glucose concentrations in blood | Amplitude of post-meal blood glucose following supplement(s) and controlled meal | 4 hours, two occasions |
| Concentrations of insulin postprandially in blood | Insulin appearance in blood following supplement(s) and controlled meal | 4 hours, two occasions |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of amino acids postprandially in blood | Total amino acid appearance in blood following supplement(s) and controlled meal | 4 hours, two occasions |
| Concentrations of postprandial appetite hormones |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leigh Breen, PhD | Contact | (0)1214144109 | +44 | l.breen@bham.ac.uk |
| Marie Korzepa, PhD | Contact | m.korzepa@bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Leigh Breen, PhD | University of Birmingham and University of Leciester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham | Enrolling by invitation | Birmingham | West Midlands | B15 2TT | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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Placebo-controlled partial crossover
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| Glycaemic control with different doses of whey protein | Dietary Supplement | Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein. |
|
Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal
| 4 hours, two occasions |
| Rate of gastric emptying | Rate of gastric emptying using acetaminophen appearance in the blood following its consumption with supplement(s) and controlled meal. | 4 hours, two occasions |
| Changes in renal function markers after each 7-day phase | Measurement of markers of renal function from urine following each 7-day phase | 2 urine samples, 2 occasions |
| Assessment of nitrogen balance from urine after each 7-day phase | Nitrogen balance from 24-hour urine collection after each 7-day phase | 24 hours, two occasions |
| Measurement of blood lipid concentration | Total cholesterol measurement in blood at rest | 1 blood draw (obtained from the first blood draw as part of 4 hour visit) |
| Optional qualitative assessment of perceptions to supplementation | Optional interview for participants to share perceptions of pre-meal supplementation | 60 minutes |
| Heartlands Hospital | Recruiting | Birmingham | United Kingdom |
|
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |