Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study

NCT03894670 | Completed DMC

• 1 other identifier: H-18026293
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The wireless motility capsule technology, SmartPill™, can be used to assess gastric emptying and gastrointestinal (GI) transit time. The SmartPill is usually ingested together with a SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a normal western diet. The primary aim of the present study is to compare effects of a SmartBar™ and a standard mixed meal on gastric emptying and GI motility.

Conditions

Healthy Participants

Keywords

Gastric emptying; Gastrointestinal transit; Food reward; Food preferences

Outcome Measures

Primary Outcomes (1)

• Gastric emptying time (minutes)

  Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual gastric emptying time.

  Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)

Secondary Outcomes (57)

• Small bowel transit time (minutes)

  Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

• Large bowel transit time (minutes)

  Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

• Total gastrointestinal transit time (minutes)

  Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

• Motility index (arbitrary unit)

  Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

• Metabolites

  0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

Study Arms (2)

SmartBar™

ACTIVE COMPARATOR

The wireless capsule technology, SmartPill™, is usually ingested together with a SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a normal western diet.

Other: SmartBar™

Standard mixed breakfast meal

EXPERIMENTAL

The SmartPill™ is ingested together with a standard mixed breakfast meal and the outcomes of interest will be compared with the SmartBar™ condition (reference).

Other: Standard mixed breakfast meal

Interventions

Standard mixed breakfast meal OTHER

The standard mixed breakfast meal consists of: 150 g yoghurt, 20 g muesli; 50 g wheat bun; 22 g rye bread; 25 g cheese; 25 g marmalade; 8 g butter; Total energy content: 500 kcal Macronutrient composition: 34 E% fat, 17 E% protein, 49 E% carbohydrate

Standard mixed breakfast meal

SmartBar™ OTHER

SmarBar™ (Medtronic, North Haven, MA, USA). Weight: 72 g; Total energy content: 260 kcal Macronutrient composition: 7 E% fat, 19 E% protein, 74 E% carbohydrate.

SmartBar™

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index: 18.5 to 24.9 kg/m2

You may not qualify if:

• Unable to understand the informed consent and the study procedures;
• Self-reported history of an eating disorder in the past three years
• HbA1c: ≥5.7 % (≥39 mmol/mol)
• Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, GI or psychiatric disease; diabetes or other endocrine disease; immunosuppression
• Current treatment with medication or medical devices which affect GI motility and transit time (prokinetics, antidiarrheals, laxatives)
• Current treatment with medication which affect glucose metabolism or appetite
• Current treatment with beta blockers or peroral steroids
• Current treatment with non-steroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin re-uptake inhibitors or opioids
• Bariatric surgery
• GI symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, celiac disease, Crohn's disease, ulcerative colitis or proctitis
• Pregnant or lactating women
• Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices
• Concomitant participation in other research studies

Sponsors & Collaborators

• Kristine Færch: lead
• University of Copenhagen: collaborator
• IMotions A/S: collaborator
• University of Leeds: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2810, Denmark

Location

Related Publications (1)

• Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.

  PMID: 37315794 DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Kristine Færch, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher and Team Leader, PhD

Model Details: The study is a randomized cross-over study including 15 healthy normal-weight individuals. On two separate test days participants ingest the SmartPill™ in combination with a SmartBar™ (standard procedure, reference) or a standard mixed breakfast meal.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 28, 2019
• Study Start: October 16, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

DK (1)