Effects of a Ketogenic Diet on Psychological Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2016-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight Mood Appetitive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is single blind, parallel arms study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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)

Study Groups

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ketogenic-mediterranean diet with phytoextracts

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).

Group Type EXPERIMENTAL

KEMEPHY

Intervention Type OTHER

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

Ketogenic Diet

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

Group Type ACTIVE_COMPARATOR

KD

Intervention Type OTHER

The group received a plan for a low carbohydrate ketogenic diet

Mediterranean Diet

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.

Group Type ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type OTHER

The group received a plan for a isocaloric Mediterranean Diet

Interventions

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Mediterranean diet

The group received a plan for a isocaloric Mediterranean Diet

Intervention Type OTHER

KEMEPHY

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

Intervention Type OTHER

KD

The group received a plan for a low carbohydrate ketogenic diet

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes