OverweightNCT04086498
Effects of a Ketogenic Diet on Psychological Outcomes
A study testing Mediterranean diet, KEMEPHY and KD in people with Overweight and Mood, run by University of Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Mood, Appetitive Behavior
- What is being tested?
- Mediterranean diet, KEMEPHY and KD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2015to 15 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex age between 20 and 35 years,
- 25<BMI>39.9 kg/m2
Who cannot join
- smokers,
- subjects under diet-treatment,
- subjects treated for diseases such as diabetes,
- cardiovascular diseases,
- depression,
- subjects doing sport more than 2 hours per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ketonemia and Glycemia Variations During Ketogenic and Mediterranean Weight Loss Diets on Appetite Levels, Executive Functions and Mood
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.
Read the 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.
- Conditions
- Overweight, Mood, Appetitive Behavior
- Being tested
- Mediterranean diet, KEMEPHY, KD
- Keywords
- ketogenic diet, Mediterranean diet, ketones, glycaemia, executive functions
- Medical subject headings
- Overweight, Appetitive Behavior, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ketogenic-mediterranean diet with phytoextracts | Experimental | 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). Receives: Other: KEMEPHY |
| Ketogenic Diet | Active comparator | 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 Receives: Other: KD |
| Mediterranean Diet | Active comparator | 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. Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: after 8 weeks
Secondary outcomes (6)
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
Measured: after 8 weeks
lean body mass
Body composition will be assessed by body electrical impedance analysis (BIA) that measures lean body mass in kg
Measured: after 8 weeks
fat body mass
Body composition will be assessed by body electrical impedance analysis (BIA) that measures fat body mass in kg
Measured: after 8 weeks
Mood
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".
Measured: after 8 weeks
blood glucose
to assess diets' effects on glycaemia, capillary blood will be analyzed. We measure glucose in mg/100ml
Measured: after 8 weeks
blood ketones
to assess diets' effects on ketonemia, capillary blood will be analyzed. We measure ketone in mol/L
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Apr 2015
- Primary completion30 Apr 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is single blind, parallel arms study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086498
- Sponsor's protocol ID
- KDPSY2
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw data of measured variables
Publications
Lodi A, Karsten B, Bosco G, Gomez-Lopez M, Brandao PP, Bianco A, Paoli A. The Effects of Different High-Protein Low-Carbohydrates Proprietary Foods on Blood Sugar in Healthy Subjects. J Med Food. 2016 Nov;19(11):1085-1095. doi: 10.1089/jmf.2016.0072. Epub 2016 Oct 18.
PubMed 27754766Paoli A, Bosco G, Camporesi EM, Mangar D. Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015.
PubMed 25698989Paoli A. Ketogenic diet for obesity: friend or foe? Int J Environ Res Public Health. 2014 Feb 19;11(2):2092-107. doi: 10.3390/ijerph110202092.
PubMed 24557522Paoli A, Bianco A, Grimaldi KA, Lodi A, Bosco G. Long term successful weight loss with a combination biphasic ketogenic Mediterranean diet and Mediterranean diet maintenance protocol. Nutrients. 2013 Dec 18;5(12):5205-17. doi: 10.3390/nu5125205.
PubMed 24352095Paoli A. Booster Ketones: Battling Hunger. Obesity (Silver Spring). 2018 Feb;26(2):252-253. doi: 10.1002/oby.22099. Epub 2018 Jan 10. No abstract available.
PubMed 29318785Stubbs BJ, Cox PJ, Evans RD, Cyranka M, Clarke K, de Wet H. A Ketone Ester Drink Lowers Human Ghrelin and Appetite. Obesity (Silver Spring). 2018 Feb;26(2):269-273. doi: 10.1002/oby.22051. Epub 2017 Nov 6.
PubMed 29105987
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketonemia and Glycemia Variations During Ketogenic and Mediterranean Weight Loss Diets on Appetite Levels, Executive Functions and Mood
- ClinicalTrials.gov ID
- NCT04086498
- Acronym / sponsor ID
- KDPSY2
- Conditions
- Overweight, Mood, Appetitive Behavior
- Keywords
- ketogenic diet, Mediterranean diet, ketones, glycaemia, executive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- It is single blind, parallel arms study
| Arm | Type | Receives |
|---|---|---|
| ketogenic-mediterranean diet with phytoextracts | Experimental | Other: KEMEPHYThe 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). |
| Ketogenic Diet | Active comparator | Other: KDThe 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 |
| Mediterranean Diet | Active comparator | Other: Mediterranean dietThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female sex age between 20 and 35 years,
- 25<BMI>39.9 kg/m2
Key exclusion criteria (6 listed)
- smokers,
- subjects under diet-treatment,
- subjects treated for diseases such as diabetes,
- cardiovascular diseases,
- depression,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietThe group received a plan for a isocaloric Mediterranean Diet | Other | Mediterranean Diet |
| KEMEPHYThe group received a plan for a ketogenic mediterranean with herbal extracts diet | Other | ketogenic-mediterranean diet with phytoextracts |
| KDThe group received a plan for a low carbohydrate ketogenic diet | Other | Ketogenic Diet |
Primary outcome
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).
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
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
6 secondary outcomes
body water content
Time frame: after 8 weeks
lean body mass
Time frame: after 8 weeks
fat body mass
Time frame: after 8 weeks
Mood
Time frame: after 8 weeks
blood glucose
Time frame: after 8 weeks
blood ketones
Time frame: after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 27754766Lodi A, Karsten B, Bosco G, Gomez-Lopez M, Brandao PP, Bianco A, Paoli A. The Effects of Different High-Protein Low-Carbohydrates Proprietary Foods on Blood Sugar in Healthy Subjects. J Med Food. 2016 Nov;19(11):1085-1095. doi: 10.1089/jmf.2016.0072. Epub 2016 Oct 18.
- Background: PubMed 25698989Paoli A, Bosco G, Camporesi EM, Mangar D. Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015.
- Background: PubMed 24557522Paoli A. Ketogenic diet for obesity: friend or foe? Int J Environ Res Public Health. 2014 Feb 19;11(2):2092-107. doi: 10.3390/ijerph110202092.
- Background: PubMed 24352095Paoli A, Bianco A, Grimaldi KA, Lodi A, Bosco G. Long term successful weight loss with a combination biphasic ketogenic Mediterranean diet and Mediterranean diet maintenance protocol. Nutrients. 2013 Dec 18;5(12):5205-17. doi: 10.3390/nu5125205.
- Background: PubMed 29318785Paoli A. Booster Ketones: Battling Hunger. Obesity (Silver Spring). 2018 Feb;26(2):252-253. doi: 10.1002/oby.22099. Epub 2018 Jan 10. No abstract available.
- Background: PubMed 29105987Stubbs BJ, Cox PJ, Evans RD, Cyranka M, Clarke K, de Wet H. A Ketone Ester Drink Lowers Human Ghrelin and Appetite. Obesity (Silver Spring). 2018 Feb;26(2):269-273. doi: 10.1002/oby.22051. Epub 2017 Nov 6.
- Individual participant dataSharing planned: Undecided. Raw data of measured variables
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Paoli, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet, KEMEPHY and KD in people with Overweight and Mood, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to eat and appetite (time frame: after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086498, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.