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NCT Number: NCT02417350

Ketogenic Diet - a Randomized, Controlled, Cross-over Study

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutrition

Umeå, 90187, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • Age 18-30
  • BMI 18,5-25

Exclusion criteria

  • Waist circumference ≥80 cm
  • Gravidity
  • Diabetes
  • Thyroid disease
  • Prescribed medication for high cholesterol or high blood pressure
  • Nicotine use
  • Eating disorder
  • Dietary restrictions

Treatment and study plan

Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks

Other

NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.

Other

Primary outcomes

  1. 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

  2. Blood lipids Measured with LipoPrint System

    Time frame: baseline - four weeks

    Measured with LipoPrint System

Secondary outcomes

  1. Body composition Measured with DXA (Dual Energy X-Ray Absorptiometry)

    Time frame: baseline - four weeks

    Measured with DXA (Dual Energy X-Ray Absorptiometry)

  2. Gut microbiota measured with High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids

    Time frame: baseline - four weeks

    High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids

  3. Energy substrate utilization during submaximal exercise Measured with indirect calorimetry during ergometer cycling, lactate in blood.

    Time frame: baseline - four weeks

    Measured with indirect calorimetry during ergometer cycling, lactate in blood.

  4. Exercise performance

    Time frame: baseline - four weeks

    Cycling at a sub-maximal work rate with increments every 4 min for three periods, thereafter increased work rate every minute until voluntary exhaustion.

  5. Hand grip endurance

    Time frame: baseline - four weeks

    Hand grip test.

  6. Resting metabolic rate Measured with indirect calorimetry

    Time frame: baseline - four weeks

    Measured with indirect calorimetry (Quark RMR, COSMED)

  7. Hormones Measured with Bio-Plex Assays and ELISA

    Time frame: baseline - four weeks

    Measured with Bio-Plex Assays and ELISA

  8. Cognition Measured with the Stroop color-word test

    Time frame: baseline - four weeks

    Measured with the Stroop color-word test

  9. Sweet cravings Measured with a likert scale questionnaire

    Time frame: baseline - four weeks

    Measured with a likert scale questionnaire

  10. Mood and appetite Measured with a likert scale questionnaire

    Time frame: baseline - every third day during the diet intervention period - four weeks

    Measured with a likert scale questionnaire

  11. Experiences of following a particular dietary regime measured with Semi-structured interviews analyzed with content analysis

    Time frame: After finishing both study arms

    Semi-structured interviews analyzed with content analysis

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

A Randomized Controlled Diet Intervention Comparing Effects of a Ketogenic Diet Versus a National Food Administration Recommended Diet Among Healthy Female Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2015
Registry last updated
Nov 5, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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