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Impact of caloric restriction on gut barrier integrity and metabolic diseases in human

Impact of caloric restriction on gut barrier integrity and metabolic diseases in human - DieGo - Dietary Intervention and Gut Barrier Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00006210
Enrollment
20
Registered
2014-06-11
Start date
2013-10-16
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity-associated metabolic diseases

Interventions

Group 1: 20 obese women (BMI greater or equal 30 kg/m²) underwent a caloric restriction for 28 days. The dietary intervention includes a formula diet with a daily energy intake of 800kcal with additio

Sponsors

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: BMI >= 30kg/m²; Stable weight during the last 3 months (+/-2kg); Non-smokers; Signed informed consent

Exclusion criteria

Exclusion criteria: Severe general diseases, e.g. cancer, COPD, severe heart disease (e.g. pacemaker), progressive renal failure, severe psychiatric or neurological diseases; Diabetes; Continuous treatment with oral anticoagulants or antithrombotics (except ASS 100); Malabsorption syndromes; Autonomous neuropathy; Poor compliance; lactose intolerance, sucrose intolerance, sucralose intolerance; Lack of written informed consent

Design outcomes

Primary

MeasureTime frame
gut permeability (using polyethylene glycol and sugar absorption test), changes in colon microbiota, inflammation marker in plasma as well as in peripheral immune cell sub-populations. [Timeframe: baseline, after a 28–day intervention period, 14 days after intervention is terminated]

Secondary

MeasureTime frame
insulin sensitivity, body composition, basal metabolic rate, blood parameters (fasting glucose, fasting insulin, liver function, kidney function, electrolytes, lipid profile, DNA, inflammation marker), blood pressure, pulse, eating behavior. [Timeframe: baseline, after a 28–day intervention period, 14 days after intervention is terminated]

Countries

Germany

Contacts

Public ContactBeate Ott

Else Kröner-Fresenius-Zentrum für ErnährungsmedizinLehrstuhl für ErnährungsmedizinTechnische Universität München

beate.ott@tum.de08161/71-2364

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026