NCT01456572

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

4.1 years

First QC Date

September 29, 2011

Last Update Submit

October 18, 2011

Conditions

Endocrine System Diseases

Keywords

glucagon-like peptide-1peptide tyrosine tyrosineghrelinstomachsmall intestinegastric emptying

Outcome Measures

Primary Outcomes (1)

  • gastrointestinal peptide secretion

    2 hours blood sampling

Secondary Outcomes (3)

  • gastric emptying

    240 minutes end-expiratory breath sample collection

  • time needed to reach the level of satiation

    up to 30 min

  • total calorie intake

    up to 30 min

Study Arms (6)

satiation_obese weight

ACTIVE COMPARATOR

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.

Dietary Supplement: ensure plus

gastric emptying_obese weight

ACTIVE COMPARATOR

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.

Dietary Supplement: standardized test meal

gastric emptying_normal weight

PLACEBO COMPARATOR

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.

Dietary Supplement: standardized test meal

satiation_normal weight

PLACEBO COMPARATOR

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.

Dietary Supplement: ensure plus

hormone profiles_obese weight

ACTIVE COMPARATOR

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.

Dietary Supplement: ensure plus

hormone profiles_normal weight

PLACEBO COMPARATOR

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.

Dietary Supplement: ensure plus

Interventions

ensure plusDIETARY_SUPPLEMENT

17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL

hormone profiles_normal weighthormone profiles_obese weightsatiation_normal weightsatiation_obese weight
standardized test mealDIETARY_SUPPLEMENT

scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid

gastric emptying_normal weightgastric emptying_obese weight

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • age 18-45

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Phase 1 Research Unit

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Meyer-Gerspach AC, Wolnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, Steinert RE, Beglinger C. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014 Apr 22;129:265-71. doi: 10.1016/j.physbeh.2014.02.043. Epub 2014 Feb 28.

    PMID: 24582673DERIVED

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Ensure Plus

Study Officials

  • Christoph Beglinger, MD

    Phase 1 Research Unit, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 20, 2011

Study Start

January 1, 2007

Primary Completion

February 1, 2011

Study Completion

July 1, 2011

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

CH(1)