Trial Outcomes & Findings for Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus (NCT NCT01677936)

NCT ID: NCT01677936

Last Updated: 2014-04-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-04-23

Participant Flow

51 total subjects were randomized. 5 were excluded (1 snack; 4 raisin) due to lack of post-randomization evaluable data. Thus, the full analysis data set included 27 raisin and 19 snack.

Participant milestones

Measure	Raisin 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. Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm	Snack Group 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. Snacks: 100 calorie snack packs will be administered to the subjects in the snack group
Overall Study STARTED	31	20
Overall Study COMPLETED	22	15
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Measure	Raisin 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. Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm	Snack Group 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. Snacks: 100 calorie snack packs will be administered to the subjects in the snack group
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	4
Overall Study Adverse Event	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Raisin n=27 Participants 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. Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm	Snack Group n=19 Participants 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. Snacks: 100 calorie snack packs will be administered to the subjects in the snack group	Total n=46 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 8.56 • n=5 Participants	59 years STANDARD_DEVIATION 12.54 • n=7 Participants	58 years STANDARD_DEVIATION 10.22 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Gender Female	17 participants n=5 Participants	11 participants n=7 Participants	28 participants n=5 Participants
Gender Male	14 participants n=5 Participants	9 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	19 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Raisin n=22 Participants 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. Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm	Snack Group n=16 Participants 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. Snacks: 100 calorie snack packs will be administered to the subjects in the snack group
Postprandial Glucose Levels	-6 percent Standard Deviation 24	17 percent Standard Deviation 36

SECONDARY outcome

Timeframe: 12 weeks.

Raisins versus snacks: mmHg change in systolic blood pressure at week 12

Outcome measures

Measure	Raisin n=27 Participants 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. Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm	Snack Group n=19 Participants 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. Snacks: 100 calorie snack packs will be administered to the subjects in the snack group
Systolic Blood Pressure	-4.2 mmHg Standard Deviation 13	4.5 mmHg Standard Deviation 14

Adverse Events

Raisin

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Snacks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raisin n=27 participants at risk Raisin group	Snacks n=19 participants at risk Snack group
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	3.7% 1/27 • Number of events 1	0.00% 0/19

Other adverse events

Measure	Raisin n=27 participants at risk Raisin group	Snacks n=19 participants at risk Snack group
Gastrointestinal disorders Gastrointestinal complaints	29.6% 8/27 • Number of events 8	0.00% 0/19

Additional Information

Kathy Schmitz RN

Louisville Metabolic and Atherosclerosis Research Center

Phone: 502.515.5672

Email: kschmitz@lmarc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place