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

NCT ID: NCT02622490

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-05-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low carb. one meal

Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates

Group Type: ACTIVE_COMPARATOR

two test meals with two different macronutrient compositions

Intervention Type: OTHER

Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm

Low Carb. 5 small meals

Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates.

Group Type: ACTIVE_COMPARATOR

two test meals with two different macronutrient compositions

Intervention Type: OTHER

Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm

High carb. one meal

Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates

Group Type: ACTIVE_COMPARATOR

two test meals with two different macronutrient compositions

Intervention Type: OTHER

Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm

High carb. 5 meals

Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates.

Group Type: EXPERIMENTAL

two test meals with two different macronutrient compositions

Intervention Type: OTHER

Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Fredrik H Nystrom

professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik H Nystrom, MD professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Health Science, Linköping University, Sweden

Locations

University Hospital of Linkoping

Linköping, , Sweden

Countries

Sweden

Other Identifiers

DIT2

Identifier Type: -

Identifier Source: org_study_id