Appetitive Behavior, Mood, Overweight
Conditions
Keywords
ketogenic diet, Mediterranean diet, ketones, glycaemia, executive functions
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.
Interventions
OTHERMediterranean diet
The group received a plan for a isocaloric Mediterranean Diet
OTHERKEMEPHY
The group received a plan for a ketogenic mediterranean with herbal extracts diet
OTHERKD
The group received a plan for a low carbohydrate ketogenic diet
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes 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)
Intervention model description
It is single blind, parallel arms study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to eat and appetite | after 8 weeks | 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 | after 8 weeks | 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 | after 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Mood | after 8 weeks | 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. |
| body water content | after 8 weeks | Body composition will be assessed by body electrical impedance analysis (BIA) that measures Total body water and intra and extracellular water in liters |
| blood ketones | after 8 weeks | to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L |
| blood glucose | after 8 weeks | to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml |
| lean body mass | after 8 weeks | Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg |
| fat body mass | after 8 weeks | Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg |
Countries
Italy
Outcome results
None listed