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

U

University Hospital, Linkoeping

Status

Unknown

Conditions

Metabolic Rate
Serum Insulin
Sense of Satiety
Plasma Glucose
Serum Triglycerides

Treatments

Other: two test meals with two different macronutrient compositions

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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