HealthyNCT02417350
Ketogenic Diet - a Randomized, Controlled, Cross-over Study
A study testing Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks and NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks. in people with Healthy, run by Umeå University at 1 site in Sweden.
Trial summary
The investigators planned study is a randomized, controlled exploratory study of a ketogenic and a NFA (National Food Administration) recommended diet. Study participants will be female nutrition students with both knowledge and interest in dietary surveys, in order to increase motivation and adherence. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks and NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to Oct 2015
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age 18-30
- BMI 18,5-25
Who cannot join
- Waist circumference ≥80 cm
- Gravidity
- Diabetes
- Thyroid disease
- Prescribed medication for high cholesterol or high blood pressure
- Nicotine use
- Eating disorder
- Dietary restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Diet Intervention Comparing Effects of a Ketogenic Diet Versus a National Food Administration Recommended Diet Among Healthy Female Adults
The investigators planned study is a randomized, controlled exploratory study of a ketogenic and a NFA (National Food Administration) recommended diet. Study participants will be female nutrition students with both knowledge and interest in dietary surveys, in order to increase motivation and adherence. They will be provided with cooked food. The women should be weight stable and maintain their physical activity during the study, in order to evaluate how the diet itself affects various health parameters. The investigators intend to investigate diet specific biomarkers (small molecules involved in metabolism) in the blood, as well as blood lipids, body composition, gut microbiota, energy substrate utilization, exercise performance, resting metabolic rate, hormones, cognition and sweet cravings. In addition, the investigators intend to qualitatively study the experience of following both of these dietary regimes. The investigators intend to make a short and controlled study. The study is expected to reveal whether the ketogenic diet is a healthy or unhealthy diet in the short term. The investigators also expect that data from this study will be a helpful tool to measure diet adherence in future long-term studies.
Read the detailed description
Aim: The aim of this randomized controlled exploratory study is to study effects of a ketogenic diet (a low carb - high fat (LCHF) diet) compared to a National Food Administration (NFA) recommended diet (NNR2012).
Primary outcomes are blood lipids and diet specific biomarkers. Power calculations show that 20 participants are needed to obtain significant results with 90% power at the 95% significance level for the primary outcome small-dense LDL (blood lipids). The investigators calculate that 20% of the participants will drop out before the end of the study, and therefore the investigators aim to recruit a total of 24 participants.
Secondary outcomes are body composition, gut microbiota, energy substrate utilization, exercise performance, resting metabolic rate (RMR), hormones, cognition, sweet cravings, and the experience of following the two dietary regimes.
Study design: Study participants will be female nutrition students with both knowledge and interest in dietary surveys, in order to increase motivation and adherence. The women should be weight stable and maintain their physical activity during the study, in order to evaluate how the diet itself affects various health parameters.
Study participants will be provided with all food in the diet intervention. The amount and source of fat, protein and carbohydrates in the two diets are strictly defined; LCHF: Maximum 25 g carbohydrates/day (approximately 5 E%), 20 E% protein and 75 E% fat (35 E% saturated fat). NNR2012: 50 E% carbohydrates, 20 E% protein and 30 E% fat (10 E% saturated fat).
Study participants will be randomized with respect to their physical activity level to one of two study arms, with crossover design:
Study arm 1: LHCF (4 weeks) --- washout (15 weeks) --- NNR (4 weeks) Study arm 2: NNR (4 weeks) --- washout (15 weeks) --- LCHF (4 weeks)
Study participants will eat each diet for four weeks. The different diets are separated by a washout period when they eat "as usual".
Every morning during each four-week diet period the participants will measure their urine ketones by using urine ketone strips, weigh themselves and record their body weight. Any discrepancies in food intake will be recorded in a log book in which also the daily physical activity level is specified. Energy expenditure will be measured for three days during the four week periods using SenseWear activity meter (a validated and objective method) to see if energy intake matches energy expenditure.
Baseline- and outcome measurements will be performed prior to and at the end of each four-week diet period.
Qualitative measurements: When the whole diet study is completed and the research subjects have experience of eating both NNR and LCHF diet interviews will be conducted with some of the research subjects.
The study is expected to reveal whether LCHF is a healthy or unhealthy diet in the short term. The investigators also expect that data from this study will be a helpful tool to measure diet adherence in future long-term studies.
- Conditions
- Healthy
- Being tested
- Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks, NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeksOther
NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.Other
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet first | Experimental | Starting with ketogenic diet first and then switching to a NFA recommended diet Receives: Other: Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks |
| NFA recommended diet first | Experimental | Starting with NFA recommended diet first and then switching to a ketogenic diet Receives: Other: NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in blood Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
Measured: baseline - four weeks
Blood lipids Measured with LipoPrint System
Measured with LipoPrint System
Measured: baseline - four weeks
Secondary outcomes (11)
Body composition Measured with DXA (Dual Energy X-Ray Absorptiometry)
Measured with DXA (Dual Energy X-Ray Absorptiometry)
Measured: baseline - four weeks
Gut microbiota measured with High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids
High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids
Measured: baseline - four weeks
Energy substrate utilization during submaximal exercise Measured with indirect calorimetry during ergometer cycling, lactate in blood.
Measured with indirect calorimetry during ergometer cycling, lactate in blood.
Measured: baseline - four weeks
Exercise performance
Cycling at a sub-maximal work rate with increments every 4 min for three periods, thereafter increased work rate every minute until voluntary exhaustion.
Measured: baseline - four weeks
Hand grip endurance
Hand grip test.
Measured: baseline - four weeks
Resting metabolic rate Measured with indirect calorimetry
Measured with indirect calorimetry (Quark RMR, COSMED)
Measured: baseline - four weeks
Hormones Measured with Bio-Plex Assays and ELISA
Measured with Bio-Plex Assays and ELISA
Measured: baseline - four weeks
Cognition Measured with the Stroop color-word test
Measured with the Stroop color-word test
Measured: baseline - four weeks
Sweet cravings Measured with a likert scale questionnaire
Measured with a likert scale questionnaire
Measured: baseline - four weeks
Mood and appetite Measured with a likert scale questionnaire
Measured with a likert scale questionnaire
Measured: baseline - every third day during the diet intervention period - four weeks
Experiences of following a particular dietary regime measured with Semi-structured interviews analyzed with content analysis
Semi-structured interviews analyzed with content analysis
Measured: After finishing both study arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Burén, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417350
- Sponsor's protocol ID
- LCHF-100
- Status last verified
- Nov 2015
- First submitted
- 27 Mar 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Diet Intervention Comparing Effects of a Ketogenic Diet Versus a National Food Administration Recommended Diet Among Healthy Female Adults
- ClinicalTrials.gov ID
- NCT02417350
- Acronym / sponsor ID
- LCHF-100
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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 investigators planned study is a randomized, controlled exploratory study of a ketogenic and a NFA (National Food Administration) recommended diet. Study participants will be female nutrition students with both knowledge and interest in dietary surveys, in order to increase motivation and adherence. They will be provided with cooked food. The women should be weight stable and maintain their physical activity during the study, in order to evaluate how the diet itself affects various health parameters. The investigators intend to investigate diet specific biomarkers (small molecules involved in metabolism) in the blood, as well as blood lipids, body composition, gut microbiota, energy substrate utilization, exercise performance, resting metabolic rate, hormones, cognition and sweet cravings. In addition, the investigators intend to qualitatively study the experience of following both of these dietary regimes. The investigators intend to make a short and controlled study. The study is expected to reveal whether the ketogenic diet is a healthy or unhealthy diet in the short term. The investigators also expect that data from this study will be a helpful tool to measure diet adherence in future long-term studies.
Detailed description
Aim: The aim of this randomized controlled exploratory study is to study effects of a ketogenic diet (a low carb - high fat (LCHF) diet) compared to a National Food Administration (NFA) recommended diet (NNR2012).
Primary outcomes are blood lipids and diet specific biomarkers. Power calculations show that 20 participants are needed to obtain significant results with 90% power at the 95% significance level for the primary outcome small-dense LDL (blood lipids). The investigators calculate that 20% of the participants will drop out before the end of the study, and therefore the investigators aim to recruit a total of 24 participants.
Secondary outcomes are body composition, gut microbiota, energy substrate utilization, exercise performance, resting metabolic rate (RMR), hormones, cognition, sweet cravings, and the experience of following the two dietary regimes.
Study design: Study participants will be female nutrition students with both knowledge and interest in dietary surveys, in order to increase motivation and adherence. The women should be weight stable and maintain their physical activity during the study, in order to evaluate how the diet itself affects various health parameters.
Study participants will be provided with all food in the diet intervention. The amount and source of fat, protein and carbohydrates in the two diets are strictly defined; LCHF: Maximum 25 g carbohydrates/day (approximately 5 E%), 20 E% protein and 75 E% fat (35 E% saturated fat). NNR2012: 50 E% carbohydrates, 20 E% protein and 30 E% fat (10 E% saturated fat).
Study participants will be randomized with respect to their physical activity level to one of two study arms, with crossover design:
Study arm 1: LHCF (4 weeks) --- washout (15 weeks) --- NNR (4 weeks) Study arm 2: NNR (4 weeks) --- washout (15 weeks) --- LCHF (4 weeks)
Study participants will eat each diet for four weeks. The different diets are separated by a washout period when they eat "as usual".
Every morning during each four-week diet period the participants will measure their urine ketones by using urine ketone strips, weigh themselves and record their body weight. Any discrepancies in food intake will be recorded in a log book in which also the daily physical activity level is specified. Energy expenditure will be measured for three days during the four week periods using SenseWear activity meter (a validated and objective method) to see if energy intake matches energy expenditure.
Baseline- and outcome measurements will be performed prior to and at the end of each four-week diet period.
Qualitative measurements: When the whole diet study is completed and the research subjects have experience of eating both NNR and LCHF diet interviews will be conducted with some of the research subjects.
The study is expected to reveal whether LCHF is a healthy or unhealthy diet in the short term. The investigators also expect that data from this study will be a helpful tool to measure diet adherence in future long-term studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet first | Experimental | Other: Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeksStarting with ketogenic diet first and then switching to a NFA recommended diet |
| NFA recommended diet first | Experimental | Other: NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.Starting with NFA recommended diet first and then switching to a ketogenic diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Age 18-30
- BMI 18,5-25
Key exclusion criteria (8 listed)
- Waist circumference ≥80 cm
- Gravidity
- Diabetes
- Thyroid disease
- Prescribed medication for high cholesterol or high blood pressure
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 |
|---|---|---|
| Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks | Other | Ketogenic diet first |
| NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks. | Other | NFA recommended diet first |
Primary outcome
Biomarkers in blood Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
Time frame: baseline - four weeks
Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
Blood lipids Measured with LipoPrint System
Time frame: baseline - four weeks
Measured with LipoPrint System
11 secondary outcomes
Body composition Measured with DXA (Dual Energy X-Ray Absorptiometry)
Time frame: baseline - four weeks
Gut microbiota measured with High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids
Time frame: baseline - four weeks
Energy substrate utilization during submaximal exercise Measured with indirect calorimetry during ergometer cycling, lactate in blood.
Time frame: baseline - four weeks
Exercise performance
Time frame: baseline - four weeks
Hand grip endurance
Time frame: baseline - four weeks
Resting metabolic rate Measured with indirect calorimetry
Time frame: baseline - four weeks
Hormones Measured with Bio-Plex Assays and ELISA
Time frame: baseline - four weeks
Cognition Measured with the Stroop color-word test
Time frame: baseline - four weeks
Sweet cravings Measured with a likert scale questionnaire
Time frame: baseline - four weeks
Mood and appetite Measured with a likert scale questionnaire
Time frame: baseline - every third day during the diet intervention period - four weeks
Experiences of following a particular dietary regime measured with Semi-structured interviews analyzed with content analysis
Time frame: After finishing both study arms
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 5 Nov 2015.
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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.
Jonas Burén, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks and NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks. in people with Healthy, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 8 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 5 Nov 2015. 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 Sweden. 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?
Biomarkers in blood Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays (time frame: baseline - four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2015.