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Montmorency tart cherry in morbid obesity

Montmorency tart cherry in morbid obesity - CHINO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48231
Enrollment
30
Registered
2019-10-11
Start date
2019-09-02
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Morbide obesitas met bijbehorende veranderingen in lichaamssamenstelling, inflammatie en darmflora Morbid obesity morbidly overweight

Interventions

Concentrated Montmorency tart cherry juice (CherryActive, Active Edge Nutrition), 30 ml twice a day during 4 weeks.

Sponsors

Noordwest Ziekenhuisgroep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female patients aged 18-65 years, with a BMI of * 35 kg/m2 and obesity associated illness or a BMI > 40 kg/m2, that are qualified for laparoscopic gastric bypass surgery based on the IFSO criteria and have a positive advise from the Dutch Obesity Clinic (NOK) and a bariatric surgeon, and have given written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: Male sex, pregnancy, diabetes, an age below 18 or above 65, current infectious or inflammatory disease.

Design outcomes

Primary

MeasureTime frame
The effect of Montmorency tart cherry juice on MCP-1 mRNA expression in omental AT of non-diabetic adults with morbid or severe obesity qualifying for laparoscopic gastric bypass surgery.

Secondary

MeasureTime frame
The objective is to study the effect of Montmorency tart cherry juice on adipose tissue markers of oxidative stress, inflammation and macrophage infiltration, gene expression and analysis of the gut microbiome. Markers of macrophage recruitment include Netrin-1, PPAR-*, FOXA-3, ZNF-638, macrophage markers include CD-68 and CD-14, and histology traits include adipocyte size and macrophage configuration. These parameters will be investigated in 3 different fat depots: subcutaneous fat, omental fat and mesenteric fat. Stool portions from baseline and day of surgery will be frozen for microbiome analysis. Body weight at baseline and day of surgery will be measured. Visceral fat mass will be determined using Dual Energy X-ray Absorptiometry.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)