Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

NCT01850134 | Withdrawn

• 1 other identifier: BL18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Hunger

  An appetite questionnaire evaluating change from baseline during each study visit.

  Treatment Visit 1 and Treatment Visit 2

Secondary Outcomes (3)

• Fullness

  Treatment Visit 1 and Treatment Visit 2

• Desire to Eat

  Treatment Visit 1 and Treatment Visit 2

• Prospective Consumption

  Treatment Visit 1 and Treatment Visit 2

Study Arms (2)

Control Study Product

PLACEBO COMPARATOR

1 serving of control beverage.

Other: Control Study Product

Experimental Study Product

EXPERIMENTAL

1 serving of a nutritional supplement for people with diabetes.

Other: Experimental Study Product

Interventions

Experimental Study Product OTHER

Also known as: Oral nutritional supplement for people with Diabetes.

Experimental Study Product

Control Study Product OTHER

Also known as: Water beverage.

Control Study Product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes.
• Age between 18 and 75 years.
• HbA1c \> 6.0 but ≤ 8.5
• If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
• BMI \> 18.5 kg/m2 and \< 40.0 kg/m2.
• Chronic medication dosage must be stable for at least two months prior to Screening Visit.
• Subject states that they are a habitual consumer of a morning meal.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• Use of exogenous insulin or GLP-1 agonists for glucose control.
• Diagnosis of Type 1 diabetes.
• History of diabetic ketoacidosis.
• Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
• Active malignancy.
• Significant cardiovascular event \< 12 weeks prior to study entry.
• End stage organ failure or status post organ transplant.
• Active metabolic, hepatic, or gastrointestinal disease.
• Chronic, contagious, infectious disease.
• Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
• History of fainting or other adverse reactions in response to blood collection.
• Clotting or bleeding disorders.
• Allergy or intolerance to study product ingredient.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Amy Devitt-Maicher, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (2)