Metabolic SyndromeGesundLebenNCT03047655
Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
A study testing Lifestyle intervention (physical activity) and Lifestyle intervention (PUFA/isomaltulose-enriched muffin) in people with Metabolic Syndrome and NAFLD, run by German Institute of Human Nutrition at 2 sites in Germany.
Trial summary
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome, NAFLD, Obesity
- What is being tested?
- Lifestyle intervention (physical activity) and Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Jan 2017to Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertension
- NAFLD
- obesity
- hyperuricemia
- dyslipoproteinemia
Who cannot join
- prediabetes / overt diabetes mellitus
- present cancer
- systemic infection
- chronic inflammatory disease
- recent stroke / myocardial infarction (6 months)
- pregnancy
- addiction / severe psychiatric diseases
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Not yet recruiting
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, 14458
Margrit Kemper, Dr. med., 033200 88 2775, margrit.kemper@dife.de
Silke Hornemann, 033200 88 2779, silke.hornemann@dife.de
- Recruiting
DIfE (German Institute for Human Nutrition)
Berlin, 12203
Stefan Kabisch, Dr. med., 030 450 514 429, stefan.kabisch@dife.de
About this study
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.
"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.
Read the detailed description
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.
The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.
Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).
- Conditions
- Metabolic Syndrome, NAFLD, Obesity, Hypertension
- Being tested
- Lifestyle intervention (physical activity), Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
- Medical subject headings
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention (physical activity)Behavioural
Dietary treatment with or without additional motivation on more physical activity
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Physical activity only | Active comparator | pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal Receives: Behavioral: Lifestyle intervention (physical activity) |
| Physical activity + Dietary treatment | Active comparator | pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal
additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks Receives: Behavioral: Lifestyle intervention (physical activity); Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lipidome pattern
complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
Measured: 6 weeks
reduction of blood pressure
systolic and diastolic blood pressure
Measured: 6 weeks
NAFLD reduction
NAFLD, estimated by fatty liver index (FLI)
Measured: 6 weeks
weight loss
loss in body weight / BMI
Measured: 6 weeks
Secondary outcomes (2)
reduction of insulin resistance
assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)
Measured: 6 weeks
improvement in quality of life
standardized questionnaires
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start9 Jan 2017
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047655
- Sponsor's protocol ID
- GesundLeben
- Acronym
- GesundLeben
- Status last verified
- Jun 2020
- First submitted
- 21 Nov 2016
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03047655
- Acronym / sponsor ID
- GesundLeben / GesundLeben
- Conditions
- Metabolic Syndrome, NAFLD, Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 Feb 2017 (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.
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.
"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.
Detailed description
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.
The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.
Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity only | Active comparator | Behavioral: Lifestyle intervention (physical activity)pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal |
| Physical activity + Dietary treatment | Active comparator | Behavioral: Lifestyle intervention (physical activity), Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hypertension
- NAFLD
- obesity
- hyperuricemia
- dyslipoproteinemia
Key exclusion criteria (7 listed)
- prediabetes / overt diabetes mellitus
- present cancer
- systemic infection
- chronic inflammatory disease
- recent stroke / myocardial infarction (6 months)
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 |
|---|---|---|
| Lifestyle intervention (physical activity)Dietary treatment with or without additional motivation on more physical activity | Behavioural | Physical activity + Dietary treatment, Physical activity only |
| Lifestyle intervention (PUFA/isomaltulose-enriched muffin) | Dietary supplement | Physical activity + Dietary treatment |
Primary outcome
change in lipidome pattern
Time frame: 6 weeks
complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
reduction of blood pressure
Time frame: 6 weeks
systolic and diastolic blood pressure
NAFLD reduction
Time frame: 6 weeks
NAFLD, estimated by fatty liver index (FLI)
weight loss
Time frame: 6 weeks
loss in body weight / BMI
2 secondary outcomes
reduction of insulin resistance
Time frame: 6 weeks
improvement in quality of life
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention (physical activity) and Lifestyle intervention (PUFA/isomaltulose-enriched muffin) in people with Metabolic Syndrome and NAFLD, run by German Institute of Human Nutrition at 2 sites in Germany.
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 7 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Stefan Kabisch, Dr.med. (030 450 514 429, stefan.kabisch@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in lipidome pattern (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020.