Trial Outcomes & Findings for Cancer Dietary Objectives Study (NCT NCT00561977)

NCT ID: NCT00561977

Last Updated: 2011-09-02

Results Overview

Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 6 mos
• Results posted on: 2011-09-02

Participant Flow

Of 78 patients responding to advertisements at UMass Medical School intranet, 36 (41%) eligible overweight and obese patients were consented to participate in the study. Dates of recruitment were May-August 2007.

23 ineligible, 5 refused screening, 12 patients put on waiting list, 2 patients dropped prior to randomization due to pregnancy. 2 patients added from waiting list to active participation.

Participant milestones

Measure	High Fiber Diet high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	9	10
Overall Study NOT COMPLETED	0	3	2

Reasons for withdrawal

Measure	High Fiber Diet high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Overall Study Withdrawal by Subject	0	2	1
Overall Study Pregnancy	0	1	1

Baseline Characteristics

Cancer Dietary Objectives Study

Baseline characteristics by cohort

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=12 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=12 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age Continuous	48.42 years STANDARD_DEVIATION 9.77 • n=5 Participants	53.00 years STANDARD_DEVIATION 12.5 • n=7 Participants	41.33 years STANDARD_DEVIATION 15.89 • n=5 Participants	47.58 years STANDARD_DEVIATION 13.48 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 mos

Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Dietary Quality	38.78 score Standard Deviation 3.20	41.18 score Standard Deviation 3.51	39.76 score Standard Deviation 3.70

PRIMARY outcome

Timeframe: 3 months

The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).	44.90 score Standard Deviation 3.51	44.90 score Standard Deviation 3.20	43.75 score Standard Deviation 3.70

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Change in Weight From Baseline to 3 Months	-7.0 pounds Standard Deviation 2.0	-9.1 pounds Standard Deviation 2.2	-6.7 pounds Standard Deviation 2.3

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Change in Weight From Baseline to 6 Months	-9.1 pounds Standard Deviation 2.0	-10.2 pounds Standard Deviation 2.2	-7.0 pounds Standard Deviation 2.3

SECONDARY outcome

Timeframe: 3 months

kilocalories

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Change in Calories From Baseline to 3 Months	-464.05 calories Standard Deviation 94.52	-190.90 calories Standard Deviation 103.54	-638.91 calories Standard Deviation 109.15

SECONDARY outcome

Timeframe: 6 months

kilocalories

Outcome measures

Measure	High Fiber Diet n=12 Participants high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=9 Participants low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=10 Participants Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Change in Calories From Baseline to 6 Months	-364.82 calories Standard Deviation 94.52	-187.19 calories Standard Deviation 103.54	-626.32 calories Standard Deviation 109.15

Adverse Events

High Fiber Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Saturated Fat

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Combination Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Fiber Diet n=12 participants at risk high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.	Low Saturated Fat n=12 participants at risk low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.	Combination Diet n=12 participants at risk Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Vascular disorders loss of consciousness from blood draw	0.00% 0/12	8.3% 1/12 • Number of events 1	0.00% 0/12

Additional Information

Barbara Olendzki, RD MPH LDN

UMass Medical School

Phone: 508-856-5195

Email: barbara.olendzki@umassmed.edu

Results disclosure agreements

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