Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes (NCT03785951) | Clinical Trial Compass
UnknownNot Applicable
Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes
United Kingdom40 participantsStarted 2018-12
Plain-language summary
Higher than average blood sugar (glucose) levels are linked to an increased risk of developing type 2 diabetes. As such, there is interest in identifying dietary factors that could lower blood glucose to help reduce the number of people with this disease. Findings from some human studies indicate that dairy products, especially a milk protein (whey), may help the control of blood glucose levels. However, there is a need for further studies to confirm these findings in individuals without diabetes but with higher than average blood glucose levels.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI 20-35 kg/m2
* HbA1c (5.7 - 6.5%) or (38.8 - 47.5 mmol/mol)
* Fasting glucose 5.5-6.9 mmol/l
* Fasting total cholesterol \<7.5mmol/l
* Fasting triacylglycerol \<4.0 mmol/l
* Not having a milk, gluten or wheat allergy or lactose intolerability
* Not having diabetes (HbA1c \< 47 mmol/mol) or \< 6.5%
* Not suffering from cardiovascular, renal, gastrointestinal, respiratory, endocrine or liver disease
* Not having hypertension
* Not diagnosed with cancer
* Not having surgery in the previous 6 months
* Not consuming more than the recommended intake of alcohol (\>14 unit/wk)
* Not being a blood donor 3 months prior to or during the study.
* Not taking extra protein powder supplements in the previous 2 months
* Not anaemic (Haemoglobin ≥115 g/l for women and ≥ 130 g/l for men)
* Not taking medication for raised blood lipids, high blood pressure or for inflammatory conditions.
Exclusion Criteria:
• Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fasting and day long glucose levels
Timeframe: Before and after each 8 week intervention.
2
Change in fasting and day long insulin levels
Timeframe: Before and after each 8 week intervention.