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Completed

NCT Number: NCT04086498

Effects of a Ketogenic Diet on Psychological Outcomes

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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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Exercise Lab, DSB, University of Padova

Padova, 35131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean Diet

Other

The group received a plan for a isocaloric Mediterranean Diet

KEMEPHY

Other

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

KD

Other

The group received a plan for a low carbohydrate ketogenic diet

Primary outcomes

  1. Motivation to eat and appetite

    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).

  2. cognitive task1

    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

  3. Cognitive task2

    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

Secondary outcomes

  1. body water content

    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

  2. lean body mass

    Time frame: after 8 weeks

    Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg

  3. fat body mass

    Time frame: after 8 weeks

    Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg

  4. Mood

    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".

  5. blood glucose

    Time frame: after 8 weeks

    to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml

  6. blood ketones

    Time frame: after 8 weeks

    to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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