OverweightPREVENTOMICSNCT04590989
Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences
A study testing Personalized Nutrition Plan and Non-Personalized Nutrition Plan in people with Overweight and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Metabolic Syndrome
- What is being tested?
- Personalized Nutrition Plan and Non-Personalized Nutrition Plan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Oct 2020to 14 Jun 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged 18-65 years
- Body mass index (in kg/m2) of ≥27,0 and <40,0 (overweight and class I and II obesity)
- Elevated waist circumference (Men>94,0 cm; Women>80,0 cm)
- Possess a smart mobile phone
- Able to provide written informed consent
Who cannot join
- Diagnosis of diabetes
- History or diagnosis of heart, liver or kidney disease
- Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
- Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the primary outcomes of the study
- Being lactating, pregnant or planning to become pregnant within the study period
- Participation within another clinical trial
Show all 11Show fewer
- Other blood donation during the study
- Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening.
- Having allergies or food intolerances
- No or limited access to the Internet
- Participants not able to comply with the study protocol judged by Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study
The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general dietary recommendations in overweight subjects with elevated waist circumference.
Read the detailed description
PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan.
To demonstrate the potential for personalization of the platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity.
The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast following the national guidelines of macronutrient composition. The control group (n=50) will receive meals based on general dietary recommendations whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages.
Our hypothesis is that delivery of personalized meal/plan through the PREVENTOMICS platform integrated with e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Being tested
- Personalized Nutrition Plan, Non-Personalized Nutrition Plan
- Keywords
- Nutrigenomics, Nutrigenetics, Metabolomics, Microbiome, Precision nutrition, Personalized nutrition, Weight management, Body weight, Obesity
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Nutrition PlanOther
- Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations.
- Personalized behavioral change program via electronic push notifications by ONMI
Non-Personalized Nutrition PlanOther
- Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized.
- Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization).
| Study group | Role | What they receive |
|---|---|---|
| Personalized Plan (PP) | Experimental | Each subject in the PP group will be allocated to one of five clusters based on their metabolic and genetic health biomarkers from samples of urine, plasma, serum, and saliva. 58 biomarkers will be included to characterize the 5 metabolic clusters/processes in the PREVENTOMICS platform: 1) oxidative stress; 2) inflammation; 3) carbohydrate metabolism; 4) lipid metabolism; 5) microbiota-generated metabolites. Eurecat Nutrition Team has prepared a list of recommended food items to increase and food to exclude/limit from the diet for each cluster. The list will be adopted by Simple Feast in creating five different menus that will encompass the 12 meals/week of breakfasts and dinners for the five different metabolic clusters. Additionally, subjects will receive personalized actionable "Do's" push notifications by ONMI. The messages are personalized based on user reports from the behavioral questionnaire at V2 in addition to inputs from the nutritional recommendations of food to increase. Receives: Other: Personalized Nutrition Plan |
| Control Group | Placebo comparator | Dietary intervention:
The second group of 50 subjects will receive meals from Simple Feast, after integrating their metabolic profile and other blood biomarkers by PREVENTOMICS, which are based on the national dietary guidelines.
Behavioral intervention:
Subjects will also receive nudges, after filling out ONMI's behavioral questionnaire at V2, but that will not be personalized (i.e. basic information that is available online from NHS and WHO). Receives: Other: Non-Personalized Nutrition Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).
Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.
Measured: Baseline (V2) and week 10 (V3).
Secondary outcomes (6)
Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference
Body composition is evaluated by DXA scans at V2 and V3. Body weight will be measured after the participant has voided their bladder using a calibrated digital scale. weight will be recorded in kg to the nearest 0.1 kg. Body Mass Index (BMI) is calculated by the person's weight in kilograms divided by the square of their height in meters. Waist circumference will be measured with a stretch-resistant tape at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest. It will be measured twice to the nearest 0.5 cm and thereafter an average will be calculated.
Measured: Baseline (V2) and week 10 (V3).
Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP)
Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Measured: Baseline (V2) and week 10 (V3).
Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10
Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Measured: Baseline (V2) and week 10 (V3).
Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10
Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Measured: Baseline (V2) and week 10 (V3).
Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10
Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Measured: Baseline (V2) and week 10 (V3).
Change in blood pressure from baseline to week 10
Systolic and diastolic blood pressure and pulse will be measured using a validated automatic device on the arm after 5-10 min rest in a resting position. The measurement is taken three times with a 1 min rest in between (four times if the last two measurements deviate >5 mmHg), and the reading is recorded to the nearest 1 mmHg. A mean value of the last two readings is used. The same arm will be used for all measurements at all visits.
Measured: Baseline (V2) and week 10 (V3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 Oct 2020
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eurecat will grant Simple feast and ONMI access to users' profile via PREVENTOMICS Platform in order to know which group the subject is assigned to and intervene accordingly. The profile includes the assigned group/cluster along with nutritional recommendations of each subject. 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals and recipes from Simple Feast. The control group (50 subjects) will receive meals based on general dietary recommendations whereas the meals of the personalized plan group (50 subjects) are personalized based on an analysis of their metabolic biomarkers, genetics, preferences, health status, and lifestyle habits. In addition, ONMI will deliver a personally tailored and actionable behavior change program (Do-Omics) to the personalized plan group while the control group will receive general advice.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Eurecat, Simple Feast, Alimentómica, University of Parma, ONMI
- Responsible party
- Principal investigator, Mads Fiil Hjorth, University of Copenhagen
- Investigators
- Mads F Hjorth, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590989
- Sponsor's protocol ID
- B-361
- Acronym
- PREVENTOMICS
- Status last verified
- Jul 2021
- First submitted
- 15 Oct 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Firstly, the IPD are to be shared within the PREVENTOMICS concortium. Secondly, the IPD will be made available upon request pending approval of a research proposal and statistical analysis plan and execution of a data sharing/prosessing agreement (according to GDPR). Thirdly, the IPD will be made publically available for everyone once it is completely anonymised which is 5-10 years after completion of the study (according to GDPR).
Publications
Galekop MMJ, Uyl-de Groot C, Redekop WK. Economic Evaluation of a Personalized Nutrition Plan Based on Omic Sciences Versus a General Nutrition Plan in Adults with Overweight and Obesity: A Modeling Study Based on Trial Data in Denmark. Pharmacoecon Open. 2024 Mar;8(2):313-331. doi: 10.1007/s41669-023-00461-8. Epub 2023 Dec 19.
PubMed 38113009Aldubayan MA, Mao X, Laursen MF, Pigsborg K, Christensen LH, Roager HM, Nielsen DS, Hjorth MF, Magkos F. Supplementation with inulin-type fructans affects gut microbiota and attenuates some of the cardiometabolic benefits of a plant-based diet in individuals with overweight or obesity. Front Nutr. 2023 Apr 25;10:1108088. doi: 10.3389/fnut.2023.1108088. eCollection 2023.
PubMed 37181156Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Galmes S, Palou-March A, Favari C, Wetzels M, Calleja A, Rodriguez Gomez MA, Castellnou MG, Caimari A, Galofre M, Sunol D, Escote X, Alcaide-Hidalgo JM, M Del Bas J, Gutierrez B, Krarup T, Hjorth MF, Magkos F. A double-blinded, randomized, parallel intervention to evaluate biomarker-based nutrition plans for weight loss: The PREVENTOMICS study. Clin Nutr. 2022 Aug;41(8):1834-1844. doi: 10.1016/j.clnu.2022.06.032. Epub 2022 Jun 30.
PubMed 35839545Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Mena P, Wetzels M, Calleja A, Caimari A, Del Bas J, Gutierrez B, Magkos F, Hjorth MF. Empowering consumers to PREVENT diet-related diseases through OMICS sciences (PREVENTOMICS): protocol for a parallel double-blinded randomised intervention trial to investigate biomarker-based nutrition plans for weight loss. BMJ Open. 2022 Mar 29;12(3):e051285. doi: 10.1136/bmjopen-2021-051285.
PubMed 35351696
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study
- ClinicalTrials.gov ID
- NCT04590989
- Acronym / sponsor ID
- PREVENTOMICS / B-361
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Keywords
- Nutrigenomics, Nutrigenetics, Metabolomics, Microbiome, Precision nutrition, Personalized nutrition, Weight management, Body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Fundació Eurecat, Simple Feast, Alimentómica, University of Parma, ONMI
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (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.
The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general dietary recommendations in overweight subjects with elevated waist circumference.
Detailed description
PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan.
To demonstrate the potential for personalization of the platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity.
The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast following the national guidelines of macronutrient composition. The control group (n=50) will receive meals based on general dietary recommendations whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages.
Our hypothesis is that delivery of personalized meal/plan through the PREVENTOMICS platform integrated with e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eurecat will grant Simple feast and ONMI access to users' profile via PREVENTOMICS Platform in order to know which group the subject is assigned to and intervene accordingly. The profile includes the assigned group/cluster along with nutritional recommendations of each subject. 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals and recipes from Simple Feast. The control group (50 subjects) will receive meals based on general dietary recommendations whereas the meals of the personalized plan group (50 subjects) are personalized based on an analysis of their metabolic biomarkers, genetics, preferences, health status, and lifestyle habits. In addition, ONMI will deliver a personally tailored and actionable behavior change program (Do-Omics) to the personalized plan group while the control group will receive general advice.
| Arm | Type | Receives |
|---|---|---|
| Personalized Plan (PP) | Experimental | Other: Personalized Nutrition PlanEach subject in the PP group will be allocated to one of five clusters based on their metabolic and genetic health biomarkers from samples of urine, plasma, serum, and saliva. 58 biomarkers will be included to characterize the 5 metabolic clusters/processes in the PREVENTOMICS platform: 1) oxidative stress; 2) inflammation; 3) carbohydrate metabolism; 4) lipid metabolism; 5) microbiota-generated metabolites. Eurecat Nutrition Team has prepared a list of recommended food items to increase and food to exclude/limit from the diet for each cluster. The list will be adopted by Simple Feast in creating five different menus that will encompass the 12 meals/week of breakfasts and dinners for the five different metabolic clusters. Additionally, subjects will receive personalized actionable "Do's" push notifications by ONMI. The messages are personalized based on user reports from the behavioral questionnaire at V2 in addition to inputs from the nutritional recommendations of food to increase. |
| Control Group | Placebo comparator | Other: Non-Personalized Nutrition PlanDietary intervention: The second group of 50 subjects will receive meals from Simple Feast, after integrating their metabolic profile and other blood biomarkers by PREVENTOMICS, which are based on the national dietary guidelines. Behavioral intervention: Subjects will also receive nudges, after filling out ONMI's behavioral questionnaire at V2, but that will not be personalized (i.e. basic information that is available online from NHS and WHO). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged 18-65 years
- Body mass index (in kg/m2) of ≥27,0 and <40,0 (overweight and class I and II obesity)
- Elevated waist circumference (Men>94,0 cm; Women>80,0 cm)
- Possess a smart mobile phone
- Able to provide written informed consent
Key exclusion criteria (11 listed)
- Diagnosis of diabetes
- History or diagnosis of heart, liver or kidney disease
- Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
- Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the primary outcomes of the study
- Being lactating, pregnant or planning to become pregnant within the study period
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 |
|---|---|---|
| Personalized Nutrition Plan* Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations. * Personalized behavioral change program via electronic push notifications by ONMI | Other | Personalized Plan (PP) |
| Non-Personalized Nutrition Plan* Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized. * Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization). | Other | Control Group |
Primary outcome
Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).
Time frame: Baseline (V2) and week 10 (V3).
Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.
6 secondary outcomes
Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference
Time frame: Baseline (V2) and week 10 (V3).
Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP)
Time frame: Baseline (V2) and week 10 (V3).
Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10
Time frame: Baseline (V2) and week 10 (V3).
Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10
Time frame: Baseline (V2) and week 10 (V3).
Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10
Time frame: Baseline (V2) and week 10 (V3).
Change in blood pressure from baseline to week 10
Time frame: Baseline (V2) and week 10 (V3).
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 15 Jul 2021.
- Derived from this study: PubMed 38113009Galekop MMJ, Uyl-de Groot C, Redekop WK. Economic Evaluation of a Personalized Nutrition Plan Based on Omic Sciences Versus a General Nutrition Plan in Adults with Overweight and Obesity: A Modeling Study Based on Trial Data in Denmark. Pharmacoecon Open. 2024 Mar;8(2):313-331. doi: 10.1007/s41669-023-00461-8. Epub 2023 Dec 19.
- Derived from this study: PubMed 37181156Aldubayan MA, Mao X, Laursen MF, Pigsborg K, Christensen LH, Roager HM, Nielsen DS, Hjorth MF, Magkos F. Supplementation with inulin-type fructans affects gut microbiota and attenuates some of the cardiometabolic benefits of a plant-based diet in individuals with overweight or obesity. Front Nutr. 2023 Apr 25;10:1108088. doi: 10.3389/fnut.2023.1108088. eCollection 2023.
- Derived from this study: PubMed 35839545Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Galmes S, Palou-March A, Favari C, Wetzels M, Calleja A, Rodriguez Gomez MA, Castellnou MG, Caimari A, Galofre M, Sunol D, Escote X, Alcaide-Hidalgo JM, M Del Bas J, Gutierrez B, Krarup T, Hjorth MF, Magkos F. A double-blinded, randomized, parallel intervention to evaluate biomarker-based nutrition plans for weight loss: The PREVENTOMICS study. Clin Nutr. 2022 Aug;41(8):1834-1844. doi: 10.1016/j.clnu.2022.06.032. Epub 2022 Jun 30.
- Derived from this study: PubMed 35351696Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Mena P, Wetzels M, Calleja A, Caimari A, Del Bas J, Gutierrez B, Magkos F, Hjorth MF. Empowering consumers to PREVENT diet-related diseases through OMICS sciences (PREVENTOMICS): protocol for a parallel double-blinded randomised intervention trial to investigate biomarker-based nutrition plans for weight loss. BMJ Open. 2022 Mar 29;12(3):e051285. doi: 10.1136/bmjopen-2021-051285.
- Individual participant dataSharing planned: Yes. Firstly, the IPD are to be shared within the PREVENTOMICS concortium. Secondly, the IPD will be made available upon request pending approval of a research proposal and statistical analysis plan and execution of a data sharing/prosessing agreement (according to GDPR). Thirdly, the IPD will be made publically available for everyone once it is completely anonymised which is 5-10 years after completion of the study (according to GDPR).
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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.
Mads F Hjorth, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Nutrition Plan and Non-Personalized Nutrition Plan in people with Overweight and Obesity, 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 5 inclusion and 11 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 15 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster). (time frame: Baseline (V2) and week 10 (V3).). 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 NCT04590989, which also lists 4 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 15 Jul 2021.