Status:
COMPLETED
Luxembourgish Fiber Cohort
Lead Sponsor:
Luxembourg Institute of Health
Collaborating Sponsors:
Centre Hospitalier du Luxembourg
Integrated Biobank of Luxembourg
Conditions:
Dietary Fiber
Gastrointestinal Microbiome
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Many human populations across the world are deficient in the intake of dietary fiber. This decline in fiber consumption parallels an increase in prevalence of a multitude of diseases (e.g. colorectal ...
Detailed Description
Industrialized nations tend to consume less dietary fiber and, in many nations with a Western-style diet, average consumption is half the recommended daily intake of 25-38 g/day. Dietary fiber is an i...
Eligibility Criteria
Inclusion
- Male or female:
- a. The investigators will aim for a 50:50 male:female ratio, at most 40:60. Therefore, given a sample size of N=40, if 24 eligible participants are exceed for one gender, the investigators will proceed with recruitment only for members of the underrepresented gender.
- Between 18 and 35 years of age (expand to 55 if needed)
- BMI between 18.5 ≥ BMI \> 25 kg/m2 (expand to 30 if needed)
- Born in Europe
- Current resident of Luxembourg City or Esch-sur-Alzette (expand to nearby communes if needed)
- Own a smartphone with access to Android or Apple Store applications
Exclusion
- Following a specific diet or subject to dietary restrictions for any reason
- "Vigorous" physical activity level based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) criteria
- Antibiotics usage within the past 3 months
- Probiotics usage within the past 1 month
- Laxatives usage within the past 1 month
- Other regular medication usage (e.g. ibuprofen, warfarin)
- Current or former smoker
- Gastrointestinal disorder (e.g. ulcerative colitis, Crohn's disease) diagnosis
- History of gastrointestinal surgery (excluding appendectomy)
- Metabolic disorder diagnosis or predisposition (determined by blood test at eligibility screen)
- Prediabetes: fasting glucose 100-125 mg/dL (6.1-7.0 mmol/L) and/or drug treatment of elevated glucose (8)
- Diabetes: fasting glucose ≥126 mg/dL (7.0 mmol/L) and/or drug treatment of elevated glucose and/or previously diagnosed type 1 or type 2 diabetes (8)
- Hypertriglyceridaemia: fasting triglycerides ≥1.7 mmol/L (≥150 mg/dL) and/or drug treatment for elevated triglycerides (9)
- Hypercholesterolaemia: Fasting High-density lipoprotein cholesterol (HDL-C) \< 40 mg/dL (\< 1.0 mmol/L) in men and \< 45 mg/dL (\< 1.2mmol/L) in women and/or drug treatment for reduced HDL-C (9)
- Hypertension: Systolic BP ≥130 and/or diastolic BP ≥80 mm Hg and/or drug treatment of previously diagnosed hypertension (10)
- Cancer (any type) diagnosis (note that a history of cancer that has been in remission for \>3 years may still be considered eligible)
- Immunodeficiency disorder (e.g. HIV) or autoimmune disorder (e.g. rheumatoid arthritis, lupus) diagnosis
- Neurological disorder (e.g. advanced dementia, diagnosed major depressive disorder or generalized anxiety disorder)
- Coagulation problems (e.g. hemophilia) or anemia impacting ability to participate in blood draw
- Circulatory disorder (e.g. ischemic heart diseases or history of stroke)
- Currently pregnant or lactating (breastfeeding)
- Vacation planned during study period
- Moving out of Luxembourg during the study period
- Potential conflict of interest: involved in study design, administration, data analysis, or publication of findings or belonging to the lab group of the study's principal investigators
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04352231
Start Date
February 22 2021
End Date
December 5 2022
Last Update
December 8 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Luxembourg Institute of Health
Esch-sur-Alzette, Luxembourg, 4354
2
Luxembourg Institute of Health
Strassen, Luxembourg, 4356