Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus

NCT01677936 | Completed Phase 4 Results

• 1 other identifier: Raisin DM 002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the effects of Raisins three times per day versus alternative snacks three times per day on blood sugar control and cardiovascular risk factors (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2 Diabetes Mellitus. These effects will be studied over a 12 week period.

Conditions

Diabetes Mellitus

Keywords

diabetes; blood pressure; lipid; waist circumference; BMI

Outcome Measures

Primary Outcomes (1)

• Postprandial Glucose Levels

  Raisins versus snacks: percent change in postprandial glucose levels at week 12

  12 weeks

Secondary Outcomes (1)

• Systolic Blood Pressure

  12 weeks.

Study Arms (2)

Raisin

EXPERIMENTAL

Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.

Other: Raisins

Snack Group

ACTIVE COMPARATOR

Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.

Other: Snacks

Interventions

Raisins OTHER

1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm

Raisin

Snacks OTHER

100 calorie snack packs will be administered to the subjects in the snack group

Also known as: 100 calorie snack packs

Snack Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are generally healthy men and women older than 18 years of age
• Are willing and able to undergo an informed consent process
• Have medical history of Type 2 Diabetes Mellitus
• Have hemoglobin A1c 67.5 - 10%
• Have body mass index (BMI) 25.0 to 39.9 kg/m2
• Have blood pressure \> 100 mmHg systolic or \> 70 mmHg diastolic
• Are willing and able to perform self-glucose monitoring throughout the study
• Are willing to fast before study visits
• Are willing and able to bring in their morning anti-diabetes mellitus drugs to study visits
• Women must be of non-childbearing potential defined as postmenopausal for at least 2 years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• If not menopausal or surgically sterile, then women of child-bearing potential must be willing to use:
• oral contraceptives and another acceptable form of birth control, or
• double barrier birth control methods such as condom or occlusive cap (e.g. diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film, cream, suppository).
• Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial

You may not qualify if:

• Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients
• History of greater than one drug allergy
• History of greater than one "food allergy"
• Change in anti-diabetes mellitus medication within 3 months prior to screening visit
• Change in blood pressure and/or lipid-altering medications within 1 month of screening visit
• Plans to change current anti-diabetes mellitus, blood pressure, or lipid-altering medications during course of the study
• Unwilling to maintain current anti-diabetes mellitus, blood pressure, or lipid-altering medications and their doses during the course of the study
• History of clinically significant diabetes mellitus complications, that in the opinion of the investigator, may interfere with the successful completion of the trial
• History of clinically significant diabetes mellitus kidney disease (e.g. clinically significant proteinuria)
• History of severe high or low blood sugars within the past year, as per Investigator discretion
• History of severe high or low blood sugars requiring hospitalization at any time in the past
• Subjects are excluded if within the past 6 months, they have history of myocardial infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery, peripheral vascular by-pass, stent placement, pacemaker placement, etc.), unstable angina, or alterations in treatment of stable angina
• Subjects are excluded if at any time in the past, they have history of clinically significant ventricular or atrial dysrhythmias
• Subjects are excluded if at any time in the past, they have history of New York Heart Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry out any physical activity without discomfort, symptoms of cardiac insufficiency at rest, if any physical activity is undertaken, discomfort is increased
• Subjects are excluded if at any time in the past, they have history of or known increases in QTc

Sponsors & Collaborators

• Louisville Metabolic and Atherosclerosis Research Center: lead
• California Raisin Marketing Board: collaborator

Study Sites (1)

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Snacks

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was limited by being an un-blinded, single site study of modest size.

Results Point of Contact

• Title: Kathy Schmitz RN
• Organization: Louisville Metabolic and Atherosclerosis Research Center

kschmitz@lmarc.com

502.515.5672

Study Officials

• Harold E Bays, MD

  L-MARC Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: September 3, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03

Locations

US (1)