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

NCT02622490 | Unknown

• 1 other identifier: DIT2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Metabolic rate

  The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours

  During about 3 hours

Secondary Outcomes (1)

• Effects on glucose and insulin

  3 hours

Study Arms (4)

Low carb. one meal

ACTIVE COMPARATOR

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

Other: two test meals with two different macronutrient compositions

Low Carb. 5 small meals

ACTIVE COMPARATOR

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

High carb. one meal

ACTIVE COMPARATOR

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

Other: two test meals with two different macronutrient compositions

High carb. 5 meals

EXPERIMENTAL

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

Interventions

two test meals with two different macronutrient compositions 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; High carb. one meal; Low Carb. 5 small meals; Low carb. one meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants \> 18 years with or without obesity

You may not qualify if:

• Major illnesses,
• thyroid diseases,
• need to take prednisolone,
• psychiatric disease,
• inability to understand Swedish

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

Location

Study Officials

• Fredrik H Nystrom, MD professor

  Faculty of Medicine and Health Science, Linköping University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 4, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

SE (1)