Nutrition and Exercise Lab, DSB, University of Padova
Padova, 35131, Italy
NCT Number: NCT04086498
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.
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Notify Me20 year–35 year
Female
Interventional
Not applicable
Padova, 35131, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The group received a plan for a isocaloric Mediterranean Diet
The group received a plan for a ketogenic mediterranean with herbal extracts diet
The group received a plan for a low carbohydrate ketogenic diet
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after 8 weeks
Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg
Time frame: after 8 weeks
Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg
Time frame: 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".
Time frame: after 8 weeks
to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml
Time frame: after 8 weeks
to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L
University of Padova
Other
Effects of Ketonemia and Glycemia Variations During Ketogenic and Mediterranean Weight Loss Diets on Appetite Levels, Executive Functions and Mood
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