Effects of a Ketogenic Diet on Psychological Outcomes

Overweight Clinical Trial

Official title:

Effects of Ketonemia and Glycemia Variations During Ketogenic and Mediterranean Weight Loss Diets on Appetite Levels, Executive Functions and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086498
• Other study ID #: KDPSY2
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: June 15, 2016

Study information

• Verified date: September 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 15, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetitive Behavior
• Mood
• Overweight

Intervention

Other:
• Mediterranean diet
The group received a plan for a isocaloric Mediterranean Diet
• KEMEPHY
The group received a plan for a ketogenic mediterranean with herbal extracts diet
• KD
The group received a plan for a low carbohydrate ketogenic diet

Locations

Country	Name	City	State
Italy	Nutrition and Exercise Lab, DSB, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Lodi A, Karsten B, Bosco G, Gómez-López M, Brandão 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. Epub 2016 Oct 18. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motivation to eat and appetite	Motivation to eat and appetite were investigated by Visual Analog Scale (Hill & Blundell, 1982) , a test formed by 6 scales. Each scale was 10 cm long and was labelled with vertical lines and numbers (from 0 to10) every cm. Participants had to choose which part of the scale better described how they felt. The scale investigated appetite, fullness, desire to eat, how much would participant eat, urgency of eating and worries about food through 6 questions. Moreover, also the unfullness index (10 - fullness) was taken into account (R. J. Stubbs et al., 2000).	after 8 weeks
Primary	cognitive task1	The working memory test was an adapted version of the visuo-spatial N-back (Cui, Bray, Bryant, Glover, & Reiss, 2011; Haberecht et al., 2001). It consisted in remembering the position of the letter "o" that, in each trial, could appear in different positions, since a 9-part grid divides the screen. Number of correct or incorrect answers will be counted	after 8 weeks
Primary	Cognitive task2	The executive function test was an adapted version of the inhibitory control task (Amodio et al., 2010; Cona, Arcara, Amodio, Schiff, & Bisiacchi, 2013) . The stimulus were letters that appear in the centre of the screen. The task was formed by two main parts. In the first one the participant had to respond when the letter x or y appeared on the screen; in the second part the participant had to answer only when x preceded y and then vice versa. Number of correct or incorrect answers will be counted	after 8 weeks
Secondary	body water content	Body composition will be assessed by body electrical impedance analysis (BIA) that measures Total body water and intra and extracellular water in liters	after 8 weeks
Secondary	lean body mass	Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg	after 8 weeks
Secondary	fat body mass	Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg	after 8 weeks
Secondary	Mood	The mood test was the Italian Version of the Depression Anxiety Stress Scales-21. It was a self report measure formed by 21 items that reliably measure depression (lack of incentive, dysphoria and low self-esteem) as well as anxiety (somatic and subjective symptoms), stress (irritability, impatience, tension and arousal) and general distress (related to anxiety and depression) (Bottesi et al., 2015). The responses are given on a 4-point Likert scale, ranging from zero if "I strongly disagree" to 3 if "I totally agree".	after 8 weeks
Secondary	blood glucose	to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml	after 8 weeks
Secondary	blood ketones	to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L	after 8 weeks