Associations Between Genetic Markers of Caffeine Metabolism, Appetite Hormones and Body Weight

NCT ID: NCT04514588

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-06-30

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.

Detailed Description

In more detail, participants will be recruited through local advertisements in the university campus so that to be of normal weight (BMI<25) and apparently healthy. Smokers, special population groups, i.e. athletes, pregnant women etc., those having a chronic or acute disease and those on medication will be excluded from the study.

Experimental protocol. Each volunteer will take part in 2 trials (with 7days interval between them) in a random order (using a random-number table). Female participants will be on the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite [doi.org/10.1016/j.appet.2018.01.029.]. The week preceding each experimental day, participants will be instructed to abstain from any caffeine. Furthermore, the day preceding each experimental day participants will be instructed to abstain from alcohol source and physical exercise, to get enough sleep (~7 h) and to come to the lab after an overnight fast of 10 h. Furthermore, the days before the experiment, volunteers will be asked to consume similar foods and quantities, keeping more or less constant eating patterns. Participants will arrive at the lab in the morning 9 am after an overnight fast of 10 h. They will consume a breakfast snack along with one of the three experimental drinks within 5 min. The snack will consist of 1 slice of white bread, 5 g of butter and 10 g of white sugar, providing 142 kcal (6.5% of energy from proteins, 62.5% from carbohydrates and 31.0% from lipids). The experimental drinks will be either (a) 200 mL of instant coffee providing 5 mg caffeine/kg body weight or (b) 200 mL of water (Control). After a 3-h period, participants will be offered an ad libitum lunch meal from a buffet, consisting of common Greek diet foods (pasta, tomato sauce, beef, salad, cheese, yogurt, fruit and juice). They will be instructed to consume as much food as they desire until they feel satiated, within 30 min. Researchers will record the exact amount of food consumed by weighting the foods that will be chosen and their remnants. In addition, a detailed recording of the foods participants are going to consume later in the evening will be performed from a registered dietician through recall questionnaires.

Molecular and biochemical parameters that are going to be recorded with the utilization of standardized generally accepted protocols are blood pressure, body weight and other anthropometric parameters, blood levels of ghrelin, asprosin, leptin, pancreatic polypeptide, insulin and glucose, and genetic markers that are related to caffeine metabolism (CYP1A2 rs2069514 και CYP1A2 rs762251), as well as to an obesity genetic risk score (32SNPs).

Primary and secondary outcomes Based on genotype data, participants will be categorized as fast, medium and slow metabolizers of caffeine. For sample size calculation differences of total calories consumptions between groups will be utilized as primary outcome. More specifically, since a small participation of slow metabolizers are expected, these subjects will be grouped together with medium metabolizers. A difference of total calories consumption that exceeds 20% between the two groups is considered clinically significant. Taking into account an attrition rate of 10% between the two trials (caffeine and control) a total of about 70 participants are required for the study.

Macronutrients (protein, carbohydrates and lipids) consumption, responses on visual analog scales for satiety and appetite, hormones concentrations will be studied as secondary outcomes

Conditions

Food Consumption and Appetite; Food Habits; Caffeine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

caffeine consumption and metabolism

Participants 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

Group Type: OTHER

caffeine consumption

Intervention Type: DIETARY_SUPPLEMENT

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

control

Control group will consume only water (not coffee) and the same parameters will be recorded as previously

Group Type: OTHER

caffeine consumption

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

caffeine consumption

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• normal weight (BMI<25)
• apparently healthy participants

Exclusion Criteria

• smokers,
• special population groups, i.e. athletes, pregnant women etc.,
• people with a chronic or acute disease and
• those on medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gkouskou Kalliopi

OTHER

Sponsor Role: lead

Responsible Party

Gkouskou Kalliopi

Dr Kalliopi Gkouskou principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aristides Eliopoulos, prof

Role: STUDY_CHAIR

University of Athens

Locations

University of West Attica

Aigáleo, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Kalliopi Gkouskou, PhD

Role: CONTACT

gkouskoukal@med.uoa.gr

+30693855379

Aristides Eliopoulos, Prof

Role: CONTACT

eliopag@med.uoa.gr

30 210 7462341

Facility Contacts

Dimitrios Haniotis, prof

Role: primary

dchaniotis@uniwa.gr

References

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.

Reference Type: DERIVED

PMID: 34564706 (View on PubMed)

Other Identifiers

AP336.30.06.2020

Identifier Type: -

Identifier Source: org_study_id