Metabolic Disease Clinical Trial
— 3GOfficial title:
Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
Verified date | September 2014 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
Objective: To identify how specific changes of the whole grain content in the diet affect
the host-gut microbiome interactions with implications for metabolic health .
Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting
of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60
participants will be included.
Intervention: low vs. high whole grain intake.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2015 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Body mass index (BMI): 25 - 35 kg/m2 - No medical prescribed diet - Weight stable - No blood donation during the study - Intense sporting activities less than 10h/ week - Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male) - Signed written consent Exclusion Criteria: - Pharmacological treatment; hypertension, diabetes and blood lipid regulation - Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study - Participation in another biomedical trial 1 month prior to study start - Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis - Reported chronic gastrointestinal disorders - Antibiotic treatment for 3 month prior to study start - Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start - Blood hemoglobin < 7.0 mmol/l - Blood donation within 1 month prior to study start |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Human Nutrition, University of Copenhagen | Fredriksberg |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Technical University of Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 4-days precoded food diary | Assessment of dietary intake via food frequency questionnaire as a measure of compliance | December 2014 | No |
Other | n-3 fatty acid status | Assessed as DHA percentage in a whole blood fatty acid analysis. Included as a potential effect modificator in relation to immune function and metabolic outcomes. | At the end of the intervention periods | No |
Other | Alkyresorcinol | Measured in plasma as a marker of compliance to the whole grain intervention. | At the end of the intervention periods | No |
Primary | HOMA-IR | Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) | At the end of the intervention periods | No |
Primary | Metagenomic profile | Altered quantitative metagenomics at bacterial gene- and species levels, which is a non-specific outcome, but included as the main hypothesis of the project is to test if HOMA-IR is affected via changes in the gut microbiome. | At the end of the intervention periods | No |
Secondary | Mean intestinal transit time | Participants are instructed in swallowing capsules containing different small non-invasive and non-absorbable plastic pellets for 6 consecutive days. On the seventh day they are having an X-ray of the abdomen taken. | At the end of the intervention periods | No |
Secondary | Gastrointestinal permeability, Lactulose/ mannitol ratio | 5 hours urine collection following intake of lactulose and mannitol | At the end of the intervention periods | No |
Secondary | Colonic fermentation | Measurement of breath hydrogen excretion (at before and 30, 60, 90, 120, 150, 180 after intake of standard breakfast) and plasma short-chain fatty acids (fasting and 30, 60, 120, 180 minutes after standard breakfast) | At the end of the intervention periods | No |
Secondary | Saliva microbial flora | Determination of fasting microbial composition of flora. | At the end of the intervention periods | No |
Secondary | Blood pressure | Measurement of supine systolic and diastolic blood pressure (3 times) | At the end of the intervention periods | No |
Secondary | Appetite hormones | Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) | At the end of the intervention periods | No |
Secondary | Blood lipid profile | Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) | At the end of the interventions periods | No |
Secondary | Body composition | Measurement of body fat mass and percentage via bio-impedance | At the end of the intervention periods | No |
Secondary | Subjective appetite sensation | Assessment of subjective appetite sensation via visual analogue scales | At the end of the intervention periods | No |
Secondary | Energy intake | Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast | At the end of the intervention periods | No |
Secondary | Ex vivo cytokine production | Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures. | At the end of the intervention periods | No |
Secondary | Gene expression | Assessed by mRNA qPCR in whole blood and cells from whole blood stimulation. Main focus is put on genes involved in immune function and metabolic regulation. | At the end of the intervention periods | No |
Secondary | Immune cell profiling | Assessed by flow cytometry of whole blood. | At the end of the intervention periods | No |
Secondary | Immune markers | Fasting plasma cytokines, hsCRP, and LPS/LPS-BP | At the end of the intervention periods | No |
Secondary | Blood immune cell content | Assessed by hematological cell counts | At the end of the intervention periods | No |
Secondary | Markers og glucose hemostasis | Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c | At the end of the intervention periods | No |
Secondary | Markers of one-carbon metabolism | Assessed by plasma homocystein, SAM/SAH and betain | At the end of the intervention periods | No |
Secondary | Plasma adipokines | Leptin and adiponectin | December 2015 | No |
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