Pre DiabetesWhey2GloNCT03785951
Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes
A study testing Whey Protein Isolate, Wheat Protein and Wheat Protein with Leucine in people with Pre Diabetes, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Whey Protein Isolate, Wheat Protein and Wheat Protein with Leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
Julie Lovegrove, Professor, 0044(0)1183786418, j.a.lovegrove@reading.ac.uk
Drew Price, Masters, a.j.price@pgr.reading.ac.uk
About this study
Official title: Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes But With Moderately Raised HbA1c
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.
Read the detailed description
In the UK, more than 700 people are diagnosed with type 2 diabetes each day. Higher than average (raised) fasting blood sugar (glucose) is a characteristic of those at risk of developing this disease and as a result there is significant interest in dietary factors that could reduce levels of blood glucose, lowering the frequency of type 2 diabetes in the population. Existing scientific evidence suggests an important role of dairy products and especially of whey protein in 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.
Milk contains high quality proteins, of which 80% are caseins and 20% are whey proteins. Whey proteins are a rich source of branched-chain amino acids (such as leucine) which are thought to play an important role in regulating blood glucose control and other aspects of cardiovascular disease development in both healthy and type 2 diabetic subjects. However, very few studies in non-diabetic subjects with moderately raised HbA1c, characteristic of long-term poor glucose control, have been performed to investigate how whey protein affects blood glucose levels in the body especially when consumed over the longer term in the daily diet. Furthermore, data are limited on whether the leucine content of protein plays an important role in controlling blood glucose levels.
Study aims The main aims of this study is to investigate in adults without diabetes but with moderately raised HbA1c (a long- term marker of blood glucose control) whether a protein obtained from milk and dairy products (whey) has a beneficial effect on fasting and day-long blood glucose and insulin levels compared with a plant based protein (such as wheat). The researchers will also determine if leucine, a particular amino acid (building blocks of protein) found in higher levels in whey protein plays an important role in controlling blood glucose levels.
A secondary aim will determine whether the protein interventions influence risk markers for developing heart disease and diabetes including the level of blood lipids, hormones regulating blood sugar levels and blood vessel health.
This study will test the hypothesis that the incorporation of whey protein (total protein dose 50 g/d) in the habitual diet for 8 weeks will result in an improvement in fasting and day-long blood glucose and insulin levels, and other risk markers of heart disease and diabetes compared with wheat protein (total protein dose 50 g/d), and that the addition of leucine to wheat (to match the content found in whey protein) will improve blood glucose control.
Study design This study will be a long term, double-blind, randomised, controlled, three-way, cross-over study, in which the participants will receive the protein supplements (in random order) for 8 weeks each, with a 4 week wash-out period between the different protein treatments. At the beginning and end of each protein intervention, a fasting blood sample will be collected to determine the longer term effects of the assigned protein supplement on fasting glycaemic control, insulin sensitivity, endothelial function and other cardio-metabolic risk markers, as well as non-invasive measures of blood vessel health. At the beginning of each intervention period, a subset of participants will also undergo a day-long test meal investigation to determine the short-term (postprandial) effects of the protein interventions on the study outcome measures in response to standard sequential test meals containing the assigned protein interventions.
- Conditions
- Pre Diabetes
- Being tested
- Whey Protein Isolate, Wheat Protein, Wheat Protein with Leucine
- Keywords
- HbA1c, whey, postprandial glycaemia, cardiometabolic, vascular, leucine, branched chain amino acids (BCAA), glucose control, Milk protein
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein IsolateDietary supplement
Whey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat.
50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.
Wheat ProteinDietary supplement
Enzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat.
50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.
Wheat Protein with LeucineDietary supplement
Enzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate.
50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein Isolate | Experimental | Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks Receives: Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine |
| Wheat Protein | Experimental | Subjects are asked to supplement their habitual diet with 56 g of wheat protein a day for 8 weeks Receives: Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine |
| Wheat protein with leucine | Experimental | Subjects are asked to supplement their habitual diet with 56 g of wheat protein with leucine a day for 8 weeks Receives: Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting and day long glucose levels
Blood glucose levels will be measured using a clinical chemistry analyser
Measured: Before and after each 8 week intervention.
Change in fasting and day long insulin levels
Blood insulin levels will be measured using ELISA
Measured: Before and after each 8 week intervention.
Secondary outcomes (15)
Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis
Fasting and day long measurement of vascular reactivity in the microcirculation.
Measured: Before and after each 8 week intervention.
Change in the total and HDL-cholesterol
Fasting total cholesterol and HDL-C will be measured using a clinical chemistry analyser. LDL-C will be calculated using the Friedewald formula
Measured: Before and after each 8 week intervention
Change in fructosamine
Fructosamine will be measured using a clinical chemistry analyser
Measured: Before and after each 8 week intervention
Change in C-reactive protein
C-reactive protein
Measured: Before and after each 8 week intervention
Change in pulse wave analysis
Pulse wave analysis will be measured using the Mobil-O-Graph device
Measured: Before and after each 8 week intervention
Change in blood pressure
Systolic blood pressure, diastolic blood pressure and pulse pressure
Measured: Before and after each 8 week intervention
Change in cellular adhesion molecule
VCAM and ICAM will be measured by Luminex, ICAM, P-selectin and E-selectin
Measured: Before and after each 8 week intervention
Change in selectins
P-selectin and E-selectin will be measured using Luminex
Measured: Before the start of the intervention
Change in beta-hydroxy butyrate
Beta-hydroxy butyrate will be measured using a clinical chemistry analyser as a marker of ketone bodies
Measured: Before and after each 8 week intervention
Change in insulin sensitivity
Glucose and insulin levels will be used to estimate insulin sensitivity using the Homeostatic model assessment calculation
Measured: Before and after each 8 week intervention
Change in non-esterified fatty acids
Non-esterified fatty acids will be measured using a clinical chemistry analyser
Measured: Before and after each 8 week intervention
Measurement of height
Height will be measured using a stadiometer
Measured: Before the start of the intervention
Change in body weight
Body weight will be measured using the Tanita scale
Measured: Before and after each 8 week intervention
Change in body mass index
Body mass index will be calculated from body weight and height measurement
Measured: Before and after each 8 week intervention
Change in body composition
Body composition will be measured using bioelectrical impedance.
Measured: Before and after each 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomised, controlled, 3-way, cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Barnham Benevolent Foundation, Jason and Daphne Mermikides Charitable Trust
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie Lovegrove, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785951
- Sponsor's protocol ID
- 17/56
- Acronym
- Whey2Glo
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. Br J Nutr. 2010 Sep;104(5):716-23. doi: 10.1017/S0007114510000991. Epub 2010 Apr 9.
PubMed 20377924Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.
PubMed 15531672
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes But With Moderately Raised HbA1c
- ClinicalTrials.gov ID
- NCT03785951
- Acronym / sponsor ID
- Whey2Glo / 17/56
- Conditions
- Pre Diabetes
- Keywords
- HbA1c, whey, postprandial glycaemia, cardiometabolic, vascular, leucine, branched chain amino acids (BCAA), glucose control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Barnham Benevolent Foundation, Jason and Daphne Mermikides Charitable Trust
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the UK, more than 700 people are diagnosed with type 2 diabetes each day. Higher than average (raised) fasting blood sugar (glucose) is a characteristic of those at risk of developing this disease and as a result there is significant interest in dietary factors that could reduce levels of blood glucose, lowering the frequency of type 2 diabetes in the population. Existing scientific evidence suggests an important role of dairy products and especially of whey protein in 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.
Milk contains high quality proteins, of which 80% are caseins and 20% are whey proteins. Whey proteins are a rich source of branched-chain amino acids (such as leucine) which are thought to play an important role in regulating blood glucose control and other aspects of cardiovascular disease development in both healthy and type 2 diabetic subjects. However, very few studies in non-diabetic subjects with moderately raised HbA1c, characteristic of long-term poor glucose control, have been performed to investigate how whey protein affects blood glucose levels in the body especially when consumed over the longer term in the daily diet. Furthermore, data are limited on whether the leucine content of protein plays an important role in controlling blood glucose levels.
Study aims The main aims of this study is to investigate in adults without diabetes but with moderately raised HbA1c (a long- term marker of blood glucose control) whether a protein obtained from milk and dairy products (whey) has a beneficial effect on fasting and day-long blood glucose and insulin levels compared with a plant based protein (such as wheat). The researchers will also determine if leucine, a particular amino acid (building blocks of protein) found in higher levels in whey protein plays an important role in controlling blood glucose levels.
A secondary aim will determine whether the protein interventions influence risk markers for developing heart disease and diabetes including the level of blood lipids, hormones regulating blood sugar levels and blood vessel health.
This study will test the hypothesis that the incorporation of whey protein (total protein dose 50 g/d) in the habitual diet for 8 weeks will result in an improvement in fasting and day-long blood glucose and insulin levels, and other risk markers of heart disease and diabetes compared with wheat protein (total protein dose 50 g/d), and that the addition of leucine to wheat (to match the content found in whey protein) will improve blood glucose control.
Study design This study will be a long term, double-blind, randomised, controlled, three-way, cross-over study, in which the participants will receive the protein supplements (in random order) for 8 weeks each, with a 4 week wash-out period between the different protein treatments. At the beginning and end of each protein intervention, a fasting blood sample will be collected to determine the longer term effects of the assigned protein supplement on fasting glycaemic control, insulin sensitivity, endothelial function and other cardio-metabolic risk markers, as well as non-invasive measures of blood vessel health. At the beginning of each intervention period, a subset of participants will also undergo a day-long test meal investigation to determine the short-term (postprandial) effects of the protein interventions on the study outcome measures in response to standard sequential test meals containing the assigned protein interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomised, controlled, 3-way, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Isolate | Experimental | Dietary Supplement: Whey Protein Isolate, Dietary Supplement: Wheat Protein, Dietary Supplement: Wheat Protein with LeucineSubjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks |
| Wheat Protein | Experimental | Dietary Supplement: Whey Protein Isolate, Dietary Supplement: Wheat Protein, Dietary Supplement: Wheat Protein with LeucineSubjects are asked to supplement their habitual diet with 56 g of wheat protein a day for 8 weeks |
| Wheat protein with leucine | Experimental | Dietary Supplement: Whey Protein Isolate, Dietary Supplement: Wheat Protein, Dietary Supplement: Wheat Protein with LeucineSubjects are asked to supplement their habitual diet with 56 g of wheat protein with leucine a day for 8 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (1 listed)
- Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein IsolateWhey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat. 50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake. | Dietary supplement | Wheat Protein, Wheat protein with leucine, Whey Protein Isolate |
| Wheat ProteinEnzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat. 50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake. | Dietary supplement | Wheat Protein, Wheat protein with leucine, Whey Protein Isolate |
| Wheat Protein with LeucineEnzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate. 50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks. | Dietary supplement | Wheat Protein, Wheat protein with leucine, Whey Protein Isolate |
Primary outcome
Change in fasting and day long glucose levels
Time frame: Before and after each 8 week intervention.
Blood glucose levels will be measured using a clinical chemistry analyser
Change in fasting and day long insulin levels
Time frame: Before and after each 8 week intervention.
Blood insulin levels will be measured using ELISA
15 secondary outcomes
Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis
Time frame: Before and after each 8 week intervention.
Change in the total and HDL-cholesterol
Time frame: Before and after each 8 week intervention
Change in fructosamine
Time frame: Before and after each 8 week intervention
Change in C-reactive protein
Time frame: Before and after each 8 week intervention
Change in pulse wave analysis
Time frame: Before and after each 8 week intervention
Change in blood pressure
Time frame: Before and after each 8 week intervention
Change in cellular adhesion molecule
Time frame: Before and after each 8 week intervention
Change in selectins
Time frame: Before the start of the intervention
Change in beta-hydroxy butyrate
Time frame: Before and after each 8 week intervention
Change in insulin sensitivity
Time frame: Before and after each 8 week intervention
Change in non-esterified fatty acids
Time frame: Before and after each 8 week intervention
Measurement of height
Time frame: Before the start of the intervention
Change in body weight
Time frame: Before and after each 8 week intervention
Change in body mass index
Time frame: Before and after each 8 week intervention
Change in body composition
Time frame: Before and after each 8 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Background: PubMed 20377924Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. Br J Nutr. 2010 Sep;104(5):716-23. doi: 10.1017/S0007114510000991. Epub 2010 Apr 9.
- Background: PubMed 15531672Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.
Related trials for Pre Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Lovegrove, Professor principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Isolate, Wheat Protein and Wheat Protein with Leucine in people with Pre Diabetes, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Lovegrove, Professor (0044(0)1183786418 ext. 6418, j.a.lovegrove@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting and day long glucose levels (time frame: Before and after each 8 week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.