Feeding Behavior Clinical Trial
— TIMCOfficial title:
A Randomised Controlled Trial of Meal Timing as an Acute Modifier of the Gut Microbiota and the Cardiometabolic Health of the Host.
NCT number | NCT03949543 |
Other study ID # | 200170046 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2017 |
Est. completion date | May 28, 2018 |
Verified date | May 2019 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The interplay between diet and the gut microbiota has been implicated in the onset of
cardiovascular disease. The gut microbiota displays diurnal rhythms, which may be influenced
by meal timing. This study aimed to investigate the effect of main meal consumption timing on
the microbiota and the cardiometabolic factors of the host using a cross-over RCT in healthy
adults
The main outcome measurements will be: a) changes in gut microbiota composition based on 16S
rRNA gene amplicon sequencing and shotgun metagenomics, b) changes in bacterial functional
capacity) and urinary/faecal metabolomics, c) changes in targeted bacterial metabolites,
d)Inflammatory markers
The aim of this study is to explore the effect of the timing of main meal consumption on gut
microbiota and immune response in healthy adults.
Status | Completed |
Enrollment | 17 |
Est. completion date | May 28, 2018 |
Est. primary completion date | May 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1) Healthy adult people Exclusion Criteria: 1. History of gut surgery 2. Use of antibiotics or steroids the last 3 months 3. Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary | Glasgow |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiome alpha diversity | Shannon diversity index | 7 days post-intervention | |
Primary | Faecal short chain fatty acids | Short chain fatty acids (umol/g) | 7 days post-intervention | |
Secondary | HDL | mmol/L | 7 days post-intervention | |
Secondary | LDL | mmol/L | 7 days post-intervention | |
Secondary | Triglycerides | mmol/L | 7 days post-intervention | |
Secondary | Glucose | mmol/L | 7 days post-intervention | |
Secondary | Insulin | mU/L | 7 days post-intervention | |
Secondary | IL-6 | pg/mL | 7 days post-intervention | |
Secondary | tnf alpha | pg/mL | 7 days post-intervention |
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