Associations Between Genetic Markers of Caffeine Metabolism, Appetite Hormones and Body Weight
1 other identifier
interventional
70
1 country
1
Brief Summary
The effect of caffeine on appetite and body weight is controversial. Mostly epidemiological studies exist that show either a negative effect (reduction of appetite and body weight) or no effect. In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight. Seventy subjects will participate in a cross sectional study consisting of two trials (with or without the consumption of caffeine) in order to study the aforementioned parameters. Differences of total calories consumption between fast metabolizers of caffeine and the rest of the participants is the primary outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 17, 2020
August 1, 2020
2 years
August 2, 2020
August 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
total calories consumption change
a detail recording of foods and their quantities during the day of the trial will take place
two trials (caffeine and control) two weeks apart each lasting one day
Secondary Outcomes (4)
hormones concentrations change
two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale-11-likert scale with greater numbers indicating greater appetite) change for appetite
two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale 11-likert scale with greater numbers indicating greater satiety) change for satiety
two trials (caffeine and control) two weeks apart each lasting one day
various macronutrients consumption change
two trials (caffeine and control) two weeks apart each lasting one day
Study Arms (2)
caffeine consumption and metabolism
OTHERParticipants will take part in two trials. Each trial will last one day at least one week apart. During the first trial half of the participants will consume caffeine (5mgr/kgr) and the rest only water. During the second trial a crossover design will be applied
control
OTHERControl group will consume only water (not coffee) and the same parameters will be recorded as previously
Interventions
In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight
Eligibility Criteria
You may qualify if:
- normal weight (BMI\<25)
- apparently healthy participants
You may not qualify if:
- smokers,
- special population groups, i.e. athletes, pregnant women etc.,
- people with a chronic or acute disease and
- those on medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of West Attica
Aigáleo, Attica, Greece
Related Publications (1)
Gkouskou KG, Georgiopoulos G, Vlastos I, Lazou E, Chaniotis D, Papaioannou TG, Mantzoros CS, Sanoudou D, Eliopoulos AG. CYP1A2 polymorphisms modify the association of habitual coffee consumption with appetite, macronutrient intake, and body mass index: results from an observational cohort and a cross-over randomized study. Int J Obes (Lond). 2022 Jan;46(1):162-168. doi: 10.1038/s41366-021-00972-6. Epub 2021 Sep 25.
PMID: 34564706DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aristides Eliopoulos, prof
University of Athens
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr Kalliopi Gkouskou principal investigator
Study Record Dates
First Submitted
August 2, 2020
First Posted
August 17, 2020
Study Start
June 30, 2020
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 17, 2020
Record last verified: 2020-08