Clinical trial NCT04086498: Effects of a Ketogenic Diet on Psychological Outcomes
Official title: Effects of Ketonemia and Glycemia Variations During Ketogenic and Mediterranean Weight Loss Diets on Appetite Levels, Executive Functions and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Mood
Appetitive Behavior
Keywords: ketogenic diet
Mediterranean diet
ketones
glycaemia
executive functions
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is single blind, parallel arms study
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate how glycemia and ketonemia variations during three different diet protocols: a ketogenic diet without any restriction on calories intake (KD), a calorie-restricted ketogenic-mediterranean diet (KEMEPHY) and a calorie-restricted mediterranean diet (MD) affect appetite, executive functions and mood in overweight young women.

Detailed description: Fifty overweight young women with a body mass index (BMI) greater than 25 will be randomly assigned to a ten days of ketogenic diet (KD), calorie-restricted ketogenic-mediterranean diet (KEMEPHY) or Mediterranean diet (MD). All subjects will begin the prescribed diet at the beginning of their follicular phase. Body composition, fasting blood glucose and β-hydroxybutyrate (BHB), visual analogue scale (VAS) to test appetite as well as psychological tests (one mood test and two cognitive tasks) will be obtained 5 days before the beginning and on the last day of the diet-period.

Eligibility criteria: Inclusion Criteria:

* female sex age between 20 and 35 years,
* 25\<BMI\>39.9 kg/m2

Exclusion Criteria:

* smokers,
* subjects under diet-treatment,
* subjects treated for diseases such as diabetes,
* cardiovascular diseases,
* depression,
* subjects doing sport more than 2 hours per week.

Primary outcomes:
measure: Motivation to eat and appetite
timeFrame: after 8 weeks
measure: cognitive task1
timeFrame: after 8 weeks
measure: Cognitive task2
timeFrame: after 8 weeks
Secondary outcomes:
measure: body water content
timeFrame: after 8 weeks
measure: lean body mass
timeFrame: after 8 weeks
measure: fat body mass
timeFrame: after 8 weeks
measure: Mood
timeFrame: after 8 weeks
measure: blood glucose
timeFrame: after 8 weeks
measure: blood ketones
timeFrame: after 8 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lodi A, Karsten B, Bosco G, Gomez-Lopez M, Brandao PP, Bianco A, Paoli A. The Effects of Different High-Protein Low-Carbohydrates Proprietary Foods on Blood Sugar in Healthy Subjects. J Med Food. 2016 Nov;19(11):1085-1095. doi: 10.1089/jmf.2016.0072. Epub 2016 Oct 18.
citation: Paoli A, Bosco G, Camporesi EM, Mangar D. Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015.
citation: Paoli A. Ketogenic diet for obesity: friend or foe? Int J Environ Res Public Health. 2014 Feb 19;11(2):2092-107. doi: 10.3390/ijerph110202092.
citation: Paoli A, Bianco A, Grimaldi KA, Lodi A, Bosco G. Long term successful weight loss with a combination biphasic ketogenic Mediterranean diet and Mediterranean diet maintenance protocol. Nutrients. 2013 Dec 18;5(12):5205-17. doi: 10.3390/nu5125205.
citation: Paoli A. Booster Ketones: Battling Hunger. Obesity (Silver Spring). 2018 Feb;26(2):252-253. doi: 10.1002/oby.22099. Epub 2018 Jan 10. No abstract available.
citation: Stubbs BJ, Cox PJ, Evans RD, Cyranka M, Clarke K, de Wet H. A Ketone Ester Drink Lowers Human Ghrelin and Appetite. Obesity (Silver Spring). 2018 Feb;26(2):269-273. doi: 10.1002/oby.22051. Epub 2017 Nov 6.