ObesityPhase 4DIOGENESNCT00390637
Diet, Obesity and Genes (DiOGenes)
A Phase 4 study testing High or low Glycemic Index and high or low Protein Diet in people with Obesity and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- High or low Glycemic Index and high or low Protein Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Dec 2009
- Phase
- Phase 4
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families with healthy adults and children
Who cannot join
- Various
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet, Obesity and Genes
Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.
Read the detailed description
DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content.
The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below):
The 2 Shop Centers (Denmark \& The Netherlands):
Dietary periods and clinical examinations:
- Clinical examination 1 with anthropometry, blood etc.
- 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)
- Clinical examination 2 with anthropometry, blood etc.
- 6 months dietary intervention period 1 (SUPERMARKET period)(Family)
- Clinical examination 3 with anthropometry, blood etc.
- 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).
- Clinical examination 4 with anthropometry, blood ect.
- 12 months free-living period with no dietary intervention. (Family)
- Follow up (only body weight registration)
The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)
Dietary periods and clinical examinations:
- Clinical examination 1 with anthropometry, blood etc.
- 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only)
- Clinical examination 2 with anthropometry, blood etc.
- 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family)
- Clinical examination 3 with anthropometry, blood etc.
- 6 months free-living period with no dietary intervention. (Family)
- Follow up (only body weight registration)
Note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers", the families receive dietary instruction only "Instruction Only".
- Conditions
- Obesity, Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease
- Being tested
- High or low Glycemic Index and high or low Protein Diet
- Keywords
- Diogenes, Diet Intervention, Family, Glycemic Index, Protein
- Medical subject headings
- Obesity, Metabolic Syndrome, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High or low Glycemic Index and high or low Protein DietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low Protein, Low GI Diet Receives: Behavioral: High or low Glycemic Index and high or low Protein Diet |
| 2 | Experimental | Low Protein, High Glycemic Index Diet Receives: Behavioral: High or low Glycemic Index and high or low Protein Diet |
| 3 | Experimental | High Protein, Low Glycemic Index diet Receives: Behavioral: High or low Glycemic Index and high or low Protein Diet |
| 4 | Experimental | High Protein, High glycemic index diet Receives: Behavioral: High or low Glycemic Index and high or low Protein Diet |
| 5 | Experimental | Control diet (current recommendations) Receives: Behavioral: High or low Glycemic Index and high or low Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
For adults: body weight loss maintenance
The primary outcome is related to body weight loss maintenance after 6 month of intensive, homogeneous and therefore comparable dietary intervention across all 8 centres.
Measured: 6 Month
Secondary outcomes (8)
For adults: change in body composition
The relative loss or gain of fat mass and fat free mass
Measured: 6 Month
For adults: More than 5% weight loss maintenance
Achievement of 5% of body weight loss from randomization
Measured: 6 month
For adults: More than 10% weight loss maintenance
Achievement of 10% of body weight loss from randomization
Measured: 6 month
For adults: Drop out rate
Percentage drop out from randomisation to end of dietary intervention
Measured: 6 month
For Adults: Change in risk factors for type-2 diabetes
Change in risk factors for type-2 diabetes
Measured: 6 month
For Adults: Change in risk factors for cardiovascular disease
Change in risk factors for cardiovascular disease
Measured: 6 month
For children: Change in body weight
Change in body weight from randomization to end of intervention
Measured: 6 month
For Children: Change in BMI-Z-score
Change in BMI-Z-score from randomisation to end of intervention
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne V Astrup, Professor, Principal investigator, Institute of Human Nutrition, RVAU, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390637
- Sponsor's protocol ID
- DiOGenes FP6-2005-513946
- Other IDs
- FOOD-2004-513946
- Acronym
- DIOGENES
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2006
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saris WH, Harper A. DiOGenes: a multidisciplinary offensive focused on the obesity epidemic. Obes Rev. 2005 May;6(2):175-6. doi: 10.1111/j.1467-789x.2005.00200.x. No abstract available.
PubMed 15836468Grandjean P, Meddis A, Nielsen F, Astrup A, Budtz-Jorgensen E. Exposure to organochlorine compounds in relation to weight maintenance. Res Sq [Preprint]. 2025 Dec 12:rs.3.rs-8097114. doi: 10.21203/rs.3.rs-8097114/v1.
PubMed 41510295Kemper EJ, Blaak EE, Adriaens ME, Meex RCR. Muscle and Liver Insulin Resistance Are Associated with Distinct Plasma Protein Profiles: Data from the DiOGenes Trial. J Clin Endocrinol Metab. 2026 Mar 17;111(4):1031-1039. doi: 10.1210/clinem/dgaf562.
PubMed 41068881Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.
PubMed 38491190Vidal-Ostos F, Ramos-Lopez O, Jebb SA, Papadaki A, Pfeiffer AFH, Handjieva-Darlenska T, Kunesova M, Blaak EE, Astrup A, Martinez JA; Diet, Obesity, and Genes (Diogenes) Project. Dietary protein and the glycemic index handle insulin resistance within a nutritional program for avoiding weight regain after energy-restricted induced weight loss. Nutr Metab (Lond). 2022 Oct 19;19(1):71. doi: 10.1186/s12986-022-00707-y.
PubMed 36261843Imbert A, Vialaneix N, Marquis J, Vion J, Charpagne A, Metairon S, Laurens C, Moro C, Boulet N, Walter O, Lefebvre G, Hager J, Langin D, Saris WHM, Astrup A, Viguerie N, Valsesia A. Network Analyses Reveal Negative Link Between Changes in Adipose Tissue GDF15 and BMI During Dietary-induced Weight Loss. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e130-e142. doi: 10.1210/clinem/dgab621.
PubMed 34415992van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
PubMed 33560372Ruffieux H, Carayol J, Popescu R, Harper ME, Dent R, Saris WHM, Astrup A, Hager J, Davison AC, Valsesia A. A fully joint Bayesian quantitative trait locus mapping of human protein abundance in plasma. PLoS Comput Biol. 2020 Jun 3;16(6):e1007882. doi: 10.1371/journal.pcbi.1007882. eCollection 2020 Jun.
PubMed 32492067Turicchi J, O'Driscoll R, Finlayson G, Duarte C, Hopkins M, Martins N, Michalowska J, Larsen TM, van Baak MA, Astrup A, Stubbs RJ. Associations between the proportion of fat-free mass loss during weight loss, changes in appetite, and subsequent weight change: results from a randomized 2-stage dietary intervention trial. Am J Clin Nutr. 2020 Mar 1;111(3):536-544. doi: 10.1093/ajcn/nqz331.
PubMed 31950141van der Kolk BW, Kalafati M, Adriaens M, van Greevenbroek MMJ, Vogelzangs N, Saris WHM, Astrup A, Valsesia A, Langin D, van der Kallen CJH, Eussen SJPM, Schalkwijk CG, Stehouwer CDA, Goossens GH, Arts ICW, Jocken JWE, Evelo CT, Blaak EE. Subcutaneous Adipose Tissue and Systemic Inflammation Are Associated With Peripheral but Not Hepatic Insulin Resistance in Humans. Diabetes. 2019 Dec;68(12):2247-2258. doi: 10.2337/db19-0560. Epub 2019 Sep 6.
PubMed 31492661Valsesia A, Kulkarni SS, Marquis J, Leone P, Mironova P, Walter O, Hjorth MF, Descombes P, Hager J, Saris WH, Astrup A, Darimont C, O'Callaghan NJ. Salivary alpha-amylase copy number is not associated with weight trajectories and glycemic improvements following clinical weight loss: results from a 2-phase dietary intervention study. Am J Clin Nutr. 2019 Apr 1;109(4):1029-1037. doi: 10.1093/ajcn/nqy363.
PubMed 30982860Svendstrup M, Allin KH, Angquist L, Schnohr P, Jensen GB, Linneberg A, Thuesen B, Astrup A, Saris WHM, Vestergaard H, Sorensen TIA. Is abdominal obesity at baseline influencing weight changes in observational studies and during weight loss interventions? Am J Clin Nutr. 2018 Nov 1;108(5):913-921. doi: 10.1093/ajcn/nqy187.
PubMed 30475965Meyer A, Montastier E, Hager J, Saris WHM, Astrup A, Viguerie N, Valsesia A. Plasma metabolites and lipids predict insulin sensitivity improvement in obese, nondiabetic individuals after a 2-phase dietary intervention. Am J Clin Nutr. 2018 Jul 1;108(1):13-23. doi: 10.1093/ajcn/nqy087.
PubMed 29878058Armenise C, Lefebvre G, Carayol J, Bonnel S, Bolton J, Di Cara A, Gheldof N, Descombes P, Langin D, Saris WH, Astrup A, Hager J, Viguerie N, Valsesia A. Transcriptome profiling from adipose tissue during a low-calorie diet reveals predictors of weight and glycemic outcomes in obese, nondiabetic subjects. Am J Clin Nutr. 2017 Sep;106(3):736-746. doi: 10.3945/ajcn.117.156216. Epub 2017 Aug 9.
PubMed 28793995Hjorth MF, Ritz C, Blaak EE, Saris WH, Langin D, Poulsen SK, Larsen TM, Sorensen TI, Zohar Y, Astrup A. Pretreatment fasting plasma glucose and insulin modify dietary weight loss success: results from 3 randomized clinical trials. Am J Clin Nutr. 2017 Aug;106(2):499-505. doi: 10.3945/ajcn.117.155200. Epub 2017 Jul 5.
PubMed 28679551
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Obesity and Genes
- ClinicalTrials.gov ID
- NCT00390637
- Acronym / sponsor ID
- DIOGENES / DiOGenes FP6-2005-513946
- Conditions
- Obesity, Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease
- Keywords
- Diogenes, Diet Intervention, Family, Glycemic Index, Protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Oct 2006 (estimated)
- 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.
Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.
Detailed description
DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content.
The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below):
The 2 Shop Centers (Denmark \& The Netherlands):
Dietary periods and clinical examinations:
- Clinical examination 1 with anthropometry, blood etc.
- 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)
- Clinical examination 2 with anthropometry, blood etc.
- 6 months dietary intervention period 1 (SUPERMARKET period)(Family)
- Clinical examination 3 with anthropometry, blood etc.
- 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).
- Clinical examination 4 with anthropometry, blood ect.
- 12 months free-living period with no dietary intervention. (Family)
- Follow up (only body weight registration)
The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)
Dietary periods and clinical examinations:
- Clinical examination 1 with anthropometry, blood etc.
- 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only)
- Clinical examination 2 with anthropometry, blood etc.
- 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family)
- Clinical examination 3 with anthropometry, blood etc.
- 6 months free-living period with no dietary intervention. (Family)
- Follow up (only body weight registration)
Note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers", the families receive dietary instruction only "Instruction Only".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: High or low Glycemic Index and high or low Protein DietLow Protein, Low GI Diet |
| 2 | Experimental | Behavioral: High or low Glycemic Index and high or low Protein DietLow Protein, High Glycemic Index Diet |
| 3 | Experimental | Behavioral: High or low Glycemic Index and high or low Protein DietHigh Protein, Low Glycemic Index diet |
| 4 | Experimental | Behavioral: High or low Glycemic Index and high or low Protein DietHigh Protein, High glycemic index diet |
| 5 | Experimental | Behavioral: High or low Glycemic Index and high or low Protein DietControl diet (current recommendations) |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Families with healthy adults and children
Key exclusion criteria (1 listed)
- Various
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 |
|---|---|---|
| High or low Glycemic Index and high or low Protein Diet | Behavioural | 1, 2, 3, 4, 5 |
Primary outcome
For adults: body weight loss maintenance
Time frame: 6 Month
The primary outcome is related to body weight loss maintenance after 6 month of intensive, homogeneous and therefore comparable dietary intervention across all 8 centres.
8 secondary outcomes
For adults: change in body composition
Time frame: 6 Month
For adults: More than 5% weight loss maintenance
Time frame: 6 month
For adults: More than 10% weight loss maintenance
Time frame: 6 month
For adults: Drop out rate
Time frame: 6 month
For Adults: Change in risk factors for type-2 diabetes
Time frame: 6 month
For Adults: Change in risk factors for cardiovascular disease
Time frame: 6 month
For children: Change in body weight
Time frame: 6 month
For Children: Change in BMI-Z-score
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 15836468Saris WH, Harper A. DiOGenes: a multidisciplinary offensive focused on the obesity epidemic. Obes Rev. 2005 May;6(2):175-6. doi: 10.1111/j.1467-789x.2005.00200.x. No abstract available.
- Derived from this study: PubMed 41510295Grandjean P, Meddis A, Nielsen F, Astrup A, Budtz-Jorgensen E. Exposure to organochlorine compounds in relation to weight maintenance. Res Sq [Preprint]. 2025 Dec 12:rs.3.rs-8097114. doi: 10.21203/rs.3.rs-8097114/v1.
- Derived from this study: PubMed 41068881Kemper EJ, Blaak EE, Adriaens ME, Meex RCR. Muscle and Liver Insulin Resistance Are Associated with Distinct Plasma Protein Profiles: Data from the DiOGenes Trial. J Clin Endocrinol Metab. 2026 Mar 17;111(4):1031-1039. doi: 10.1210/clinem/dgaf562.
- Derived from this study: PubMed 38491190Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.
- Derived from this study: PubMed 36261843Vidal-Ostos F, Ramos-Lopez O, Jebb SA, Papadaki A, Pfeiffer AFH, Handjieva-Darlenska T, Kunesova M, Blaak EE, Astrup A, Martinez JA; Diet, Obesity, and Genes (Diogenes) Project. Dietary protein and the glycemic index handle insulin resistance within a nutritional program for avoiding weight regain after energy-restricted induced weight loss. Nutr Metab (Lond). 2022 Oct 19;19(1):71. doi: 10.1186/s12986-022-00707-y.
- Derived from this study: PubMed 34415992Imbert A, Vialaneix N, Marquis J, Vion J, Charpagne A, Metairon S, Laurens C, Moro C, Boulet N, Walter O, Lefebvre G, Hager J, Langin D, Saris WHM, Astrup A, Viguerie N, Valsesia A. Network Analyses Reveal Negative Link Between Changes in Adipose Tissue GDF15 and BMI During Dietary-induced Weight Loss. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e130-e142. doi: 10.1210/clinem/dgab621.
- Derived from this study: PubMed 33560372van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
- Derived from this study: PubMed 32492067Ruffieux H, Carayol J, Popescu R, Harper ME, Dent R, Saris WHM, Astrup A, Hager J, Davison AC, Valsesia A. A fully joint Bayesian quantitative trait locus mapping of human protein abundance in plasma. PLoS Comput Biol. 2020 Jun 3;16(6):e1007882. doi: 10.1371/journal.pcbi.1007882. eCollection 2020 Jun.
- Derived from this study: PubMed 31950141Turicchi J, O'Driscoll R, Finlayson G, Duarte C, Hopkins M, Martins N, Michalowska J, Larsen TM, van Baak MA, Astrup A, Stubbs RJ. Associations between the proportion of fat-free mass loss during weight loss, changes in appetite, and subsequent weight change: results from a randomized 2-stage dietary intervention trial. Am J Clin Nutr. 2020 Mar 1;111(3):536-544. doi: 10.1093/ajcn/nqz331.
- Derived from this study: PubMed 31492661van der Kolk BW, Kalafati M, Adriaens M, van Greevenbroek MMJ, Vogelzangs N, Saris WHM, Astrup A, Valsesia A, Langin D, van der Kallen CJH, Eussen SJPM, Schalkwijk CG, Stehouwer CDA, Goossens GH, Arts ICW, Jocken JWE, Evelo CT, Blaak EE. Subcutaneous Adipose Tissue and Systemic Inflammation Are Associated With Peripheral but Not Hepatic Insulin Resistance in Humans. Diabetes. 2019 Dec;68(12):2247-2258. doi: 10.2337/db19-0560. Epub 2019 Sep 6.
- Derived from this study: PubMed 30982860Valsesia A, Kulkarni SS, Marquis J, Leone P, Mironova P, Walter O, Hjorth MF, Descombes P, Hager J, Saris WH, Astrup A, Darimont C, O'Callaghan NJ. Salivary alpha-amylase copy number is not associated with weight trajectories and glycemic improvements following clinical weight loss: results from a 2-phase dietary intervention study. Am J Clin Nutr. 2019 Apr 1;109(4):1029-1037. doi: 10.1093/ajcn/nqy363.
- Derived from this study: PubMed 30475965Svendstrup M, Allin KH, Angquist L, Schnohr P, Jensen GB, Linneberg A, Thuesen B, Astrup A, Saris WHM, Vestergaard H, Sorensen TIA. Is abdominal obesity at baseline influencing weight changes in observational studies and during weight loss interventions? Am J Clin Nutr. 2018 Nov 1;108(5):913-921. doi: 10.1093/ajcn/nqy187.
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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.
Arne V Astrup, Professor principal investigator
Institute of Human Nutrition, RVAU, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High or low Glycemic Index and high or low Protein Diet in people with Obesity and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 25 Oct 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For adults: body weight loss maintenance (time frame: 6 Month). 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 NCT00390637, which also lists 32 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 25 Oct 2018.