Overview

This trial is active, not recruiting.

Conditions metabolic rate, plasma glucose, serum insulin, serum triglycerides, sense of satiety
Treatment two test meals with two different macronutrient compositions
Sponsor University Hospital, Linkoeping
Start date September 2015
End date September 2016
Trial size 28 participants
Trial identifier NCT02622490, DIT2

Summary

Thirty participants without serious concomitant diseases consume either a high- or a low carb. meal either as one single meal or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates
two test meals with two different macronutrient compositions
Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm
(Active Comparator)
Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates.
two test meals with two different macronutrient compositions
Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm
(Active Comparator)
Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates
two test meals with two different macronutrient compositions
Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm
(Experimental)
Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates.
two test meals with two different macronutrient compositions
Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm

Primary Outcomes

Measure
Metabolic rate
time frame: During about 3 hours

Secondary Outcomes

Measure
Effects on glucose and insulin
time frame: 3 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Healthy participants > 18 years with or without obesity Exclusion Criteria: - Major illnesses, - thyroid diseases, - need to take prednisolone, - psychiatric disease, - inability to understand Swedish

Additional Information

Official title Diet-induced Thermogenesis 2
Principal investigator Fredrik H Nystrom, MD professor
Description Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital, Linkoeping.