Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome (GesundLeben)

German Institute of Human Nutrition

Status: Unknown

Conditions: Hypertension; Obesity; NAFLD; Metabolic Syndrome

Treatments: Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin); Behavioral: Lifestyle intervention (physical activity)

Study type: Interventional

Funder types: Other

Identifiers

NCT03047655

GesundLeben

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypertension
• NAFLD
• obesity
• hyperuricemia
• dyslipoproteinemia

Exclusion criteria

• prediabetes / overt diabetes mellitus
• present cancer
• systemic infection
• chronic inflammatory disease
• recent stroke / myocardial infarction (6 months)
• pregnancy
• addiction / severe psychiatric diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Physical activity only

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle intervention (physical activity)

Physical activity + Dietary treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle intervention (physical activity)

Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)