Effects of a Ketogenic Diet on Psychological Outcomes

University of Padova50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Overweight Mood Appetitive Behavior

Interventions

Mediterranean dietOTHER

The group received a plan for a isocaloric Mediterranean Diet

KEMEPHYOTHER

The group received a plan for a ketogenic mediterranean with herbal extracts diet

KDOTHER

The group received a plan for a low carbohydrate ketogenic diet

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, Italy

Outcomes

Primary Outcomes

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).

Time frame: after 8 weeks

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

Time frame: after 8 weeks

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

Time frame: after 8 weeks

Secondary Outcomes

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

Time frame: after 8 weeks

lean body mass

Data from ClinicalTrials.gov

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