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

NCT02417350 | Completed

• 1 other identifier: LCHF-100
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

  baseline - four weeks

• Blood lipids Measured with LipoPrint System

  Measured with LipoPrint System

  baseline - four weeks

Secondary Outcomes (11)

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

  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

• Exercise performance

  baseline - four weeks

• Hand grip endurance

  baseline - four weeks

Study Arms (2)

Ketogenic diet first

EXPERIMENTAL

Starting with ketogenic diet first and then switching to a NFA recommended diet

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Age 18-30
• BMI 18,5-25

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Food and Nutrition

Umeå, Umeå, 90187, Sweden

Location

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jonas Burén, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

SE (1)