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

Not Applicable

• Conditions: Plasma Glucose; Metabolic Rate; Serum Insulin; Sense of Satiety; Serum Triglycerides
• Interventions: Other: two test meals with two different macronutrient compositions

• Registration Number: NCT02622490
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low carb. one meal	two test meals with two different macronutrient compositions	Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates
Low Carb. 5 small meals	two test meals with two different macronutrient compositions	Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates.
High carb. one meal	two test meals with two different macronutrient compositions	Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates
High carb. 5 meals	two test meals with two different macronutrient compositions	Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates.

Primary Outcome Measures

Name	Time	Method
Metabolic rate	During about 3 hours	The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours

Secondary Outcome Measures

Name	Time	Method
Effects on glucose and insulin	3 hours	Repeated test of glucose and insulin for three hours after test meal

Trial Locations

Locations (1)

University Hospital of Linkoping; 🇸🇪 Linkoping, Sweden