Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

University Hospital Basel

Status and phase: Completed; Phase 1

Conditions: Endocrine System Diseases

Treatments: Dietary Supplement: standardized test meal; Dietary Supplement: ensure plus

Study type: Interventional

Funder types: Other

Identifiers

NCT01456572

EKBB 122/09

Details and patient eligibility

About

The purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

Full description

Obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. These facts demonstrate the need for an improved understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. To achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy volunteers.

Time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient drink.

Enrollment: 65 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy subjects
• age 18-45

Exclusion criteria

• smoking
• substance abuse
• regular intake of medication
• medical or psychiatric illness
• gastrointestinal disorders or food allergies

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 6 patient groups, including a placebo group

satiation_obese weight

Active Comparator group

Description:

Obese subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.

Treatment:

Dietary Supplement: ensure plus

gastric emptying_obese weight

Active Comparator group

Description:

Obese subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.

Treatment:

Dietary Supplement: standardized test meal

gastric emptying_normal weight

Placebo Comparator group

Description:

Normal weight subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.

Treatment:

Dietary Supplement: standardized test meal

satiation_normal weight

Placebo Comparator group

Description:

Normal weight subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.

Treatment:

Dietary Supplement: ensure plus

hormone profiles_obese weight

Active Comparator group

Description:

Obese subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.

Treatment:

Dietary Supplement: ensure plus

hormone profiles_normal weight

Placebo Comparator group

Description:

Normal weight subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.

Treatment:

Dietary Supplement: ensure plus