Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food (DIT2)

Diet-induced Thermogenesis 2

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Rate; Plasma Glucose; Serum Insulin; Serum Triglycerides; Sense of Satiety
• Intervention / Treatment: Other: two test meals with two different macronutrient compositions

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden, 58185
    • University Hospital of Linkoping

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low carb. one meal; Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates	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
Active Comparator: Low Carb. 5 small meals; Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates.	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
Active Comparator: High carb. one meal; Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates	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
Experimental: High carb. 5 meals; Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic rate	The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours	During about 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on glucose and insulin	Repeated test of glucose and insulin for three hours after test meal	3 hours

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Fredrik H Nystrom, MD professor, Faculty of Medicine and Health Science, Linköping University, Sweden

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DIT2