NCT01777893

Brief Summary

Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been initiated to find out the most effective lifestyle-components (diet and physical activity) in the prevention of Type-2 diabetes. The project consists of a randomized lifestyle-intervention with the more specific aim to determine the preventative impact of a high-protein and low-GI diet in combination with moderate or high intensity physical activity compared with a moderate-protein and moderate GI diet in combination with the same activity levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and older adults. The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain, Netherlands, UK) and Australia and New Zealand. A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and adolescents aged 10-18 y) will be recruited. All adult participants are first treated by a low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and adolescents are treated separately with a conventional weight-reduction diet, with-out a specific aim for absolute weight loss. The adult participants are randomized into two different diet interventions and two exercise interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by weight-maintenance (prevention of relapse in reduced body weight) and by independent metabolic effects of diet and physical activity. The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3 years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI, adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c. For children and adolescents: Change in insulin resistance at 2 years after randomization to high protein versus moderate protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as well as physiological improvement of health with respect to pre-diabetic characteristics. Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2 diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity physical activity will be superior compared to moderate-intensity physical activity.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
8 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

4.8 years

First QC Date

January 24, 2013

Last Update Submit

March 18, 2019

Conditions

Keywords

Type-2 diabetes mellitusObesityHigh protein dietLow GIPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Incidence of type 2 diabetes

    For adults by OGTT Incidence of type 2 diabetes, in high protein versus medium protein diet, measured during 3 years after baseline and based on WHO/IDF criteria: Fasting plasma glucose (FPG) \> 7.0 mmol/l (126 mg/dl) or, 75 g oral glucose tolerance test (OGTT) with FPG \> 7.0 mmol/l (126 mg/dl) and/or 2 hour plasma glucose \> 11.1 mmol/l (200 mg/dl) or, Glycated haemoglobin (HbA1c) \> 6.5% (48 mmol/mol), or Random plasma glucose \> 11.1 mmol/l (200 mg/dl) in the presence of classical diabetes symptoms. For children and adolescents: Change in insulin resistance at 2 years after randomization to high protein versus medium protein diet, measured by insulin resistance analysed by the homeostatic model (HOMA-IR).

    3 years

Secondary Outcomes (25)

  • Incidence of type-2 diabetes

    2 years

  • Change in HbA1c

    3 years

  • Change in body weight (kg or percent) and waist 8cm), hip (cm) and thigh circumference (cm)

    3 years

  • Change in body composition - fat mass and fat-free mass (kg, proportion of body weight)

    3 years

  • Proportion of subjects maintaining at least 0, 5 or 10% weight loss

    3 years

  • +20 more secondary outcomes

Other Outcomes (1)

  • Direct and indirect costs.

    3 years

Study Arms (4)

HP-HI

EXPERIMENTAL

High protein/ high intensity physical activity

Behavioral: High protein/ high intensity physical activity (HP-HI)

HP-MI

EXPERIMENTAL

High protein/ moderate intensity physical activity

Behavioral: High protein / moderate intensity physical activity (HP-MI)

MP-HI

EXPERIMENTAL

Moderate protein/ high intensity physical activity

Behavioral: Moderate protein/ high intensity physical activity (MP-HI)

MP-MI

EXPERIMENTAL

Moderate protein/ moderate intensity physical activity

Behavioral: Moderate protein/ moderate intensity physical activity (MP-MI)

Interventions

Participants follow a high protein diet and a high intensity physical activity intervention

HP-HI

Participants follow a high protein diet and moderate intensity physical activity intervention

HP-MI

Participants follow a moderate protein diet and a high intensity physical activity intervention

MP-HI

Participants follow a moderate protein diet and moderate intensity physical activity intervention

MP-MI

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For adults:
  • Age 25 - 70 years:
  • From mid 2013 - mid 2014, subjects aged 25-45 and 55-70 years were enrolled. From mid 2014, subjects aged 46-54 years were also enrolled.
  • Overweight or obesity status BMI\>25 kg/m2
  • Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l.
  • Informed consent required
  • Ethnic group - No restrictions
  • Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
  • Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
  • Other - Able to participate at CID's during normal working hours.
  • For children and adolescents:
  • Age 10-18 years
  • Age-adjusted value corresponding to BMI\>25 kg/m2 (Cole et al. 2000)
  • Since the prevalence of pre-diabetes among children with overweight or obesity is low, it is not feasible to include exclusively pre-diabetic children (according to criteria of the IDF).
  • Therefore, insulin resistant over-weight/obese children will be included, defined as: HOMA-IR ≥ 2.0 for Tanner stage \> 2. No HOMA criteria is used for Tanner stage 1 and 2.
  • +5 more criteria

You may not qualify if:

  • Based on interview and/or questionnaire, individuals with the following problems will be excluded:
  • Medical conditions as known by the subjects:
  • Diabetes mellitus (other than gestational diabetes mellitus);
  • Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease ;
  • Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months;
  • Advanced chronic renal impairment;
  • Significant liver disease e.g. cirrhosis (fatty liver disease allowed);
  • Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed);
  • Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption;
  • Previous bariatric surgery;
  • Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program);
  • A recent surgical procedure until after full convalescence (investigators judgement);
  • Transmissible blood-borne diseases e.g. hepatitis B, HIV;
  • Psychiatric illness (e.g. major depression, bipolar disorder).
  • Medication:
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Sydney

Sydney, NSW 2006, Australia

Location

Medical University Sofia

Sofia, 1403, Bulgaria

Location

University of Copenhagen

Frederiksberg, 1958, Denmark

Location

University of Helsinki

Helsinki, 00014, Finland

Location

University of Maastricht

Maastricht, 6200, Netherlands

Location

University of Auckland

Auckland, 1024, New Zealand

Location

University of Navarra

Pamplona, 31008, Spain

Location

University of Nottingham Medical School

Nottingham, NG7 2UH, United Kingdom

Location

Swansea University

Swansea, SA1 8EN, United Kingdom

Location

Related Publications (24)

  • Zhu R, Guo J, Huttunen-Lenz M, Silvestre M, Stratton G, Macdonald IA, Handjieva-Darlenska T, Handjiev S, Navas-Carretero S, Poppitt SD, Fogelholm M, Martinez-Urbistondo D, Martinez JA, Raben A, Brand-Miller J. Long-term effects of dietary protein and carbohydrate quality on prediabetes remission: results from the PREVIEW randomised multinational diabetes prevention trial. Diabetologia. 2026 Jan;69(1):81-92. doi: 10.1007/s00125-025-06560-x. Epub 2025 Oct 15.

  • Lim JJ, Prodhan UK, Silvestre MP, Liu AY, McLay J, Fogelholm M, Raben A, Poppitt SD, Cameron-Smith D. Low serum glycine strengthens the association between branched-chain amino acids and impaired insulin sensitivity assessed before and after weight loss in a population with pre-diabetes: The PREVIEW_NZ cohort. Clin Nutr. 2024 Dec;43(12):17-25. doi: 10.1016/j.clnu.2024.09.047. Epub 2024 Oct 2.

  • Jiang YC, Lai K, Muirhead RP, Chung LH, Huang Y, James E, Liu XT, Wu J, Atkinson FS, Yan S, Fogelholm M, Raben A, Don AS, Sun J, Brand-Miller JC, Qi Y. Deep serum lipidomics identifies evaluative and predictive biomarkers for individualized glycemic responses following low-energy diet-induced weight loss: a PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World (PREVIEW) substudy. Am J Clin Nutr. 2024 Oct;120(4):864-878. doi: 10.1016/j.ajcnut.2024.08.015. Epub 2024 Aug 23.

  • Huttunen-Lenz M, Hansen S, Raben A, Westerterp-Plantenga M, Adam T, Macdonald I, Stratton G, Swindell N, Martinez JA, Navas-Carretero S, Handjieva-Darlenska T, Handjiev S, Poppitt SD, Silvestre MP, Larsen TM, Vestentoft PS, Fogelholm M, Jalo E, Brand-Miller J, Muirhead R, Schlicht W. Hybrid Evaluation of a Lifestyle Change Program to Prevent the Development of Type 2 Diabetes Among Individuals With Prediabetes: Intended and Observed Changes in Intervening Mechanisms. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241248223. doi: 10.1177/21501319241248223.

  • Huttunen-Lenz M, Raben A, Adam T, Macdonald I, Taylor MA, Stratton G, Mackintosh K, Martinez JA, Handjieva-Darlenska T, Bogdanov GA, Poppitt SD, Silvestre MP, Fogelholm M, Jalo E, Brand-Miller J, Muirhead R, Schlicht W. Socio-economic factors, mood, primary care utilization, and quality of life as predictors of intervention cessation and chronic stress in a type 2 diabetes prevention intervention (PREVIEW Study). BMC Public Health. 2023 Aug 30;23(1):1666. doi: 10.1186/s12889-023-16569-9.

  • Zhu R, Craciun I, Bernhards-Werge J, Jalo E, Poppitt SD, Silvestre MP, Huttunen-Lenz M, McNarry MA, Stratton G, Handjiev S, Handjieva-Darlenska T, Navas-Carretero S, Sundvall J, Adam TC, Drummen M, Simpson EJ, Macdonald IA, Brand-Miller J, Muirhead R, Lam T, Vestentoft PS, Faerch K, Martinez JA, Fogelholm M, Raben A. Age- and sex-specific effects of a long-term lifestyle intervention on body weight and cardiometabolic health markers in adults with prediabetes: results from the diabetes prevention study PREVIEW. Diabetologia. 2022 Aug;65(8):1262-1277. doi: 10.1007/s00125-022-05716-3. Epub 2022 May 25.

  • Jian C, Silvestre MP, Middleton D, Korpela K, Jalo E, Broderick D, de Vos WM, Fogelholm M, Taylor MW, Raben A, Poppitt S, Salonen A. Gut microbiota predicts body fat change following a low-energy diet: a PREVIEW intervention study. Genome Med. 2022 May 23;14(1):54. doi: 10.1186/s13073-022-01053-7.

  • Zhu R, Fogelholm M, Jalo E, Poppitt SD, Silvestre MP, Moller G, Huttunen-Lenz M, Stratton G, Sundvall J, Macdonald IA, Handjieva-Darlenska T, Handjiev S, Navas-Carretero S, Martinez JA, Muirhead R, Brand-Miller J, Raben A. Animal-based food choice and associations with long-term weight maintenance and metabolic health after a large and rapid weight loss: The PREVIEW study. Clin Nutr. 2022 Apr;41(4):817-828. doi: 10.1016/j.clnu.2022.02.002. Epub 2022 Feb 8.

  • Zhu R, Larsen TM, Poppitt SD, Silvestre MP, Fogelholm M, Jalo E, Hatonen KA, Huttunen-Lenz M, Taylor MA, Simpson L, Mackintosh KA, McNarry MA, Navas-Carretero S, Martinez JA, Handjieva-Darlenska T, Handjiev S, Drummen M, Westerterp-Plantenga MS, Lam T, Vestentoft PS, Muirhead R, Brand-Miller J, Raben A. Associations of quantity and quality of carbohydrate sources with subjective appetite sensations during 3-year weight-loss maintenance: Results from the PREVIEW intervention study. Clin Nutr. 2022 Jan;41(1):219-230. doi: 10.1016/j.clnu.2021.11.038. Epub 2021 Dec 3.

  • Navas-Carretero S, San-Cristobal R, Siig Vestentoft P, Brand-Miller JC, Jalo E, Westerterp-Plantenga M, Simpson EJ, Handjieva-Darlenska T, Stratton G, Huttunen-Lenz M, Lam T, Muirhead R, Poppitt S, Pietilainen KH, Adam T, Taylor MA, Handjiev S, McNarry MA, Hansen S, Brodie S, Silvestre MP, Macdonald IA, Boyadjieva N, Mackintosh KA, Schlicht W, Liu A, Larsen TM, Fogelholm M, Raben A, Martinez JA. Appraisal of Triglyceride-Related Markers as Early Predictors of Metabolic Outcomes in the PREVIEW Lifestyle Intervention: A Controlled Post-hoc Trial. Front Nutr. 2021 Nov 1;8:733697. doi: 10.3389/fnut.2021.733697. eCollection 2021.

  • Drummen M, Adam TC, Macdonald IA, Jalo E, Larssen TM, Martinez JA, Handjiev-Darlenska T, Brand-Miller J, Poppitt SD, Stratton G, Pietilainen KH, Taylor MA, Navas-Carretero S, Handjiev S, Muirhead R, Silvestre MP, Swindell N, Huttunen-Lenz M, Schlicht W, Lam T, Sundvall J, Raman L, Feskens E, Tremblay A, Raben A, Westerterp-Plantenga MS. Associations of changes in reported and estimated protein and energy intake with changes in insulin resistance, glycated hemoglobin, and BMI during the PREVIEW lifestyle intervention study. Am J Clin Nutr. 2021 Nov 8;114(5):1847-1858. doi: 10.1093/ajcn/nqab247.

  • Zhu R, Fogelholm M, Larsen TM, Poppitt SD, Silvestre MP, Vestentoft PS, Jalo E, Navas-Carretero S, Huttunen-Lenz M, Taylor MA, Stratton G, Swindell N, Kaartinen NE, Lam T, Handjieva-Darlenska T, Handjiev S, Schlicht W, Martinez JA, Seimon RV, Sainsbury A, Macdonald IA, Westerterp-Plantenga MS, Brand-Miller J, Raben A. A High-Protein, Low Glycemic Index Diet Suppresses Hunger but Not Weight Regain After Weight Loss: Results From a Large, 3-Years Randomized Trial (PREVIEW). Front Nutr. 2021 Jun 1;8:685648. doi: 10.3389/fnut.2021.685648. eCollection 2021.

  • Adam TC, Drummen M, Macdonald I, Jalo E, Siig-Vestentoft P, Martinez JA, Handjiev-Darlenska T, Brand-Miller J, Poppitt S, Stratton G, Fogelholm M, Pietilainen KH, Taylor M, Navas-Carretero S, Winkens B, Handjiev S, Muirhead R, Silvestre M, Swindell N, Huttunen-Lenz M, Schlicht W, Lam T, Sundvall J, Raman L, Feskens E, Larssen TM, Tremblay A, Raben A, Westerterp-Plantenga M. Association of Psychobehavioral Variables With HOMA-IR and BMI Differs for Men and Women With Prediabetes in the PREVIEW Lifestyle Intervention. Diabetes Care. 2021 Jul;44(7):1491-1498. doi: 10.2337/dc21-0059. Epub 2021 Jun 4.

  • Zhu R, Larsen TM, Fogelholm M, Poppitt SD, Vestentoft PS, Silvestre MP, Jalo E, Navas-Carretero S, Huttunen-Lenz M, Taylor MA, Stratton G, Swindell N, Drummen M, Adam TC, Ritz C, Sundvall J, Valsta LM, Muirhead R, Brodie S, Handjieva-Darlenska T, Handjiev S, Martinez JA, Macdonald IA, Westerterp-Plantenga MS, Brand-Miller J, Raben A. Dose-Dependent Associations of Dietary Glycemic Index, Glycemic Load, and Fiber With 3-Year Weight Loss Maintenance and Glycemic Status in a High-Risk Population: A Secondary Analysis of the Diabetes Prevention Study PREVIEW. Diabetes Care. 2021 Jul;44(7):1672-1681. doi: 10.2337/dc20-3092. Epub 2021 May 27.

  • Buso MEC, Seimon RV, McClintock S, Muirhead R, Atkinson FS, Brodie S, Dodds J, Zibellini J, Das A, Wild-Taylor AL, Burk J, Fogelholm M, Raben A, Brand-Miller JC, Sainsbury A. Can a Higher Protein/Low Glycemic Index vs. a Conventional Diet Attenuate Changes in Appetite and Gut Hormones Following Weight Loss? A 3-Year PREVIEW Sub-study. Front Nutr. 2021 Mar 22;8:640538. doi: 10.3389/fnut.2021.640538. eCollection 2021.

  • Meroni A, Muirhead RP, Atkinson FS, Fogelholm M, Raben A, Brand-Miller JC. Is a Higher Protein-Lower Glycemic Index Diet More Nutritious Than a Conventional Diet? A PREVIEW Sub-study. Front Nutr. 2020 Dec 7;7:603801. doi: 10.3389/fnut.2020.603801. eCollection 2020.

  • Drummen M, Tischmann L, Gatta-Cherifi B, Cota D, Matias I, Raben A, Adam T, Westerterp-Plantenga M. Role of Endocannabinoids in Energy-Balance Regulation in Participants in the Postobese State-a PREVIEW Study. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2511-20. doi: 10.1210/clinem/dgaa193.

  • Swindell N, Rees P, Fogelholm M, Drummen M, MacDonald I, Martinez JA, Navas-Carretero S, Handjieva-Darlenska T, Boyadjieva N, Bogdanov G, Poppitt SD, Gant N, Silvestre MP, Brand-Miller J, Schlicht W, Muirhead R, Brodie S, Tikkanen H, Jalo E, Westerterp-Plantenga M, Adam T, Vestentoft PS, Larsen TM, Raben A, Stratton G. Compositional analysis of the associations between 24-h movement behaviours and cardio-metabolic risk factors in overweight and obese adults with pre-diabetes from the PREVIEW study: cross-sectional baseline analysis. Int J Behav Nutr Phys Act. 2020 Mar 4;17(1):29. doi: 10.1186/s12966-020-00936-5.

  • Drummen M, Tischmann L, Gatta-Cherifi B, Fogelholm M, Raben A, Adam TC, Westerterp-Plantenga MS. High Compared with Moderate Protein Intake Reduces Adaptive Thermogenesis and Induces a Negative Energy Balance during Long-term Weight-Loss Maintenance in Participants with Prediabetes in the Postobese State: A PREVIEW Study. J Nutr. 2020 Mar 1;150(3):458-463. doi: 10.1093/jn/nxz281.

  • Drummen M, Heinecke A, Dorenbos E, Vreugdenhil A, Raben A, Westerterp-Plantenga MS, Adam TC. Reductions in body weight and insulin resistance are not associated with changes in grey matter volume or cortical thickness during the PREVIEW study. J Neurol Sci. 2019 Aug 15;403:106-111. doi: 10.1016/j.jns.2019.06.017. Epub 2019 Jun 14.

  • Moller G, Andersen JR, Jalo E, Ritz C, Brand-Miller J, Larsen TM, Silvestre MP, Fogelholm M, Poppitt SD, Raben A, Dragsted LO. The association of dietary animal and plant protein with putative risk markers of colorectal cancer in overweight pre-diabetic individuals during a weight-reducing programme: a PREVIEW sub-study. Eur J Nutr. 2020 Jun;59(4):1517-1527. doi: 10.1007/s00394-019-02008-2. Epub 2019 May 28.

  • Christensen P, Meinert Larsen T, Westerterp-Plantenga M, Macdonald I, Martinez JA, Handjiev S, Poppitt S, Hansen S, Ritz C, Astrup A, Pastor-Sanz L, Sando-Pedersen F, Pietilainen KH, Sundvall J, Drummen M, Taylor MA, Navas-Carretero S, Handjieva-Darlenska T, Brodie S, Silvestre MP, Huttunen-Lenz M, Brand-Miller J, Fogelholm M, Raben A. Men and women respond differently to rapid weight loss: Metabolic outcomes of a multi-centre intervention study after a low-energy diet in 2500 overweight, individuals with pre-diabetes (PREVIEW). Diabetes Obes Metab. 2018 Dec;20(12):2840-2851. doi: 10.1111/dom.13466. Epub 2018 Aug 7.

  • Drummen M, Dorenbos E, Vreugdenhil ACE, Raben A, Fogelholm M, Westerterp-Plantenga MS, Adam TC. Long-term effects of increased protein intake after weight loss on intrahepatic lipid content and implications for insulin sensitivity: a PREVIEW study. Am J Physiol Endocrinol Metab. 2018 Nov 1;315(5):E885-E891. doi: 10.1152/ajpendo.00162.2018. Epub 2018 Aug 7.

  • Swindell N, Mackintosh K, McNarry M, Stephens JW, Sluik D, Fogelholm M, Drummen M, MacDonald I, Martinez JA, Handjieva-Darlenska T, Poppitt SD, Brand-Miller J, Larsen TM, Raben A, Stratton G. Objectively Measured Physical Activity and Sedentary Time Are Associated With Cardiometabolic Risk Factors in Adults With Prediabetes: The PREVIEW Study. Diabetes Care. 2018 Mar;41(3):562-569. doi: 10.2337/dc17-1057. Epub 2017 Nov 20.

MeSH Terms

Conditions

Glucose IntoleranceObesityMotor Activity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Thomas M Larsen, Ass. Prof.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR
  • Mikael Fogelholm, Professor

    University of Helsinki

    PRINCIPAL INVESTIGATOR
  • Margriet Westerterp-Plantenga, Professor

    Maastricht University

    PRINCIPAL INVESTIGATOR
  • Ian Macdonald, Professor

    University of Nottingham Medical School

    PRINCIPAL INVESTIGATOR
  • J. Alfredo Martinez, Professor

    University of Navarra

    PRINCIPAL INVESTIGATOR
  • Svetoslav Handjiev, Professor

    Medical University Sofia

    PRINCIPAL INVESTIGATOR
  • Jennie Brand-Miller, Professor

    University of Sydney

    PRINCIPAL INVESTIGATOR
  • Sally D. Poppitt, Professor

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR
  • Gareth Stratton, Professor

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 29, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations