NCT01902212

Brief Summary

The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

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

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

July 3, 2013

Last Update Submit

March 2, 2015

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

  • Gastro-Intestinal Tolerance

    Subject questionnaire

    Study Day (SD) 1-8

Secondary Outcomes (2)

  • ONS Consumption

    SD 1-8

  • Weight

    Screening and SD 8

Study Arms (1)

Oral Nutritional Supplement

EXPERIMENTAL

2 servings a day

Other: Oral Nutritional Supplement

Interventions

Oral Nutritional SupplementOTHER
Oral Nutritional Supplement

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 60 and ≤ 90 years of age.
  • Body Mass Index (BMI) \> 20 but \< 35.

You may not qualify if:

  • Subjects will be excluded from the study if they meet any of the following criteria:
  • History of diabetes
  • Antibiotic use within 1 week prior to enrollment
  • Undergone major surgery less than 3 months prior to enrollment.
  • Current active malignant disease or was treated within the last 6 months for cancer.
  • Immunodeficiency disorder.
  • Myocardial infarction within the last 3 months.
  • Chronic obstructive pulmonary disease (COPD).
  • Allergy to any of the ingredients in the study product.
  • Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
  • Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
  • Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
  • Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis Sas

Saint-Herblain, 44800, France

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jeffrey Nelson, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 18, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

FR(1)