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Effects of a Ketogenic Diet on Psychological Outcomes

Primary Purpose

Overweight, Mood, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mediterranean diet
KEMEPHY
KD
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring ketogenic diet, Mediterranean diet, ketones, glycaemia, executive functions

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Nutrition and Exercise Lab, DSB, University of Padova

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ketogenic-mediterranean diet with phytoextracts

Ketogenic Diet

Mediterranean Diet

Arm Description

The KEMEPHY diet (Paoli et al., 2011) is a mediterranean calorie-controlled ketogenic protocol (about 900 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg). Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (Lodi et al., 2016).

The KD is a protocol in which all foods containing carbohydrate are excluded, whereas meat, eggs, fish, ham, green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants can be eat without any limit. This protocol allows the use of oil, lemon juice (2 tbs/day), spices and aromatic herbs with a limitation of the use of saturated fats like butter, margarine and lard. Coffee, tea and herbal tea could be sweetened with sweeteners

The MD is a balanced calorie-controlled diet. The calorie intake was 1200 Kcal/day of which 15% were proteins, 60% carbohydrates and 25% fat. In this protocol was highlighted the use of the typical ingredients of the mediterranean tradition, such as extravirgin olive oil, vegetables, fruits, fish, lean meat and whole grain cereals.

Outcomes

Primary Outcome Measures

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).
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
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

Secondary Outcome Measures

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
lean body mass
Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg
fat body mass
Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg
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".
blood glucose
to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml
blood ketones
to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L

Full Information

First Posted
August 29, 2019
Last Updated
September 6, 2019
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT04086498
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
June 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Mood, Appetitive Behavior
Keywords
ketogenic diet, Mediterranean diet, ketones, glycaemia, executive functions

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is single blind, parallel arms study
Masking
InvestigatorOutcomes Assessor
Masking Description
Raw data are encoded with 3 letters assigned to each treatment (A, B and C). Investigators and outcomes assessor do not have access to the waiting (letter-treatment)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketogenic-mediterranean diet with phytoextracts
Arm Type
Experimental
Arm Description
The KEMEPHY diet (Paoli et al., 2011) is a mediterranean calorie-controlled ketogenic protocol (about 900 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg). Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (Lodi et al., 2016).
Arm Title
Ketogenic Diet
Arm Type
Active Comparator
Arm Description
The KD is a protocol in which all foods containing carbohydrate are excluded, whereas meat, eggs, fish, ham, green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants can be eat without any limit. This protocol allows the use of oil, lemon juice (2 tbs/day), spices and aromatic herbs with a limitation of the use of saturated fats like butter, margarine and lard. Coffee, tea and herbal tea could be sweetened with sweeteners
Arm Title
Mediterranean Diet
Arm Type
Active Comparator
Arm Description
The MD is a balanced calorie-controlled diet. The calorie intake was 1200 Kcal/day of which 15% were proteins, 60% carbohydrates and 25% fat. In this protocol was highlighted the use of the typical ingredients of the mediterranean tradition, such as extravirgin olive oil, vegetables, fruits, fish, lean meat and whole grain cereals.
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Intervention Description
The group received a plan for a isocaloric Mediterranean Diet
Intervention Type
Other
Intervention Name(s)
KEMEPHY
Intervention Description
The group received a plan for a ketogenic mediterranean with herbal extracts diet
Intervention Type
Other
Intervention Name(s)
KD
Intervention Description
The group received a plan for a low carbohydrate ketogenic diet
Primary Outcome Measure Information:
Title
Motivation to eat and appetite
Description
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).
Time Frame
after 8 weeks
Title
cognitive task1
Description
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
Time Frame
after 8 weeks
Title
Cognitive task2
Description
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
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
body water content
Description
Body composition will be assessed by body electrical impedance analysis (BIA) that measures Total body water and intra and extracellular water in liters
Time Frame
after 8 weeks
Title
lean body mass
Description
Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg
Time Frame
after 8 weeks
Title
fat body mass
Description
Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg
Time Frame
after 8 weeks
Title
Mood
Description
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".
Time Frame
after 8 weeks
Title
blood glucose
Description
to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml
Time Frame
after 8 weeks
Title
blood ketones
Description
to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L
Time Frame
after 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Paoli, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition and Exercise Lab, DSB, University of Padova
City
Padova
ZIP/Postal Code
35131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Raw data of measured variables
Citations:
PubMed Identifier
27754766
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.
Results Reference
background
PubMed Identifier
25698989
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.
Results Reference
background
PubMed Identifier
24557522
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.
Results Reference
background
PubMed Identifier
24352095
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.
Results Reference
background
PubMed Identifier
29318785
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.
Results Reference
background
PubMed Identifier
29105987
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.
Results Reference
background

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Effects of a Ketogenic Diet on Psychological Outcomes

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