A Randomized Controlled Diet Intervention Comparing Effects of a Ketogenic Diet Versus a National Food Administration Recommended Diet Among Healthy Female Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Biomarkers in blood Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-30
- •BMI 18,5-25
排除标准
- •Waist circumference ≥80 cm
- •Gravidity
- •Thyroid disease
- •Prescribed medication for high cholesterol or high blood pressure
- •Nicotine use
- •Eating disorder
- •Dietary restrictions
研究组 & 干预措施
Ketogenic diet first
Starting with ketogenic diet first and then switching to a NFA recommended diet
干预措施: Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks (Other)
NFA recommended diet first
Starting with NFA recommended diet first and then switching to a ketogenic diet
干预措施: NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks. (Other)
结局指标
主要结局
Biomarkers in blood Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
时间窗: baseline - four weeks
Measured with gaschromatography (GC)-time-of-flight/mass spectrometry (MS) and Bio-Plex Assays
Blood lipids Measured with LipoPrint System
时间窗: baseline - four weeks
Measured with LipoPrint System
次要结局
- Body composition Measured with DXA (Dual Energy X-Ray Absorptiometry)(baseline - four weeks)
- Hormones Measured with Bio-Plex Assays and ELISA(baseline - four weeks)
- Gut microbiota measured with High-throughput sequencing of nucleic acids (DNA/RNA), short-chain fatty acids(baseline - four weeks)
- Energy substrate utilization during submaximal exercise Measured with indirect calorimetry during ergometer cycling, lactate in blood.(baseline - four weeks)
- Mood and appetite Measured with a likert scale questionnaire(baseline - every third day during the diet intervention period - four weeks)
- Exercise performance(baseline - four weeks)
- Resting metabolic rate Measured with indirect calorimetry(baseline - four weeks)
- Hand grip endurance(baseline - four weeks)
- Cognition Measured with the Stroop color-word test(baseline - four weeks)
- Sweet cravings Measured with a likert scale questionnaire(baseline - four weeks)
- Experiences of following a particular dietary regime measured with Semi-structured interviews analyzed with content analysis(After finishing both study arms)