Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food

Metabolic Rate Clinical Trial

— DIT2  

Official title:

Diet-induced Thermogenesis 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02622490
• Other study ID #: DIT2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2020

Study information

• Verified date: April 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Rate
• Plasma Glucose
• Sense of Satiety
• Serum Insulin
• Serum Triglycerides

Intervention

Other:
• 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

Locations

Country	Name	City	State
Sweden	University Hospital of Linkoping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic rate	The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours	During about 3 hours
Secondary	Effects on glucose and insulin	Repeated test of glucose and insulin for three hours after test meal	3 hours