Trial Outcomes & Findings for Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00435708)

Results Overview

A series of 7-day diet histories were completed by each participant at weeks 0 and 12 in order to assess baseline diet and self-reported compliance with the intervention; average daily FV intake was then hand-counted from these records;

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	1 Control Control -two or fewer portions fruit and vegetables/day	2 Intervention 5 portions fruit and vegetables/day 5 portions fruit and vegetables/day: Participants consume \> = 5 portions fruit and veg per day
Overall Study STARTED	41	40
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low FV Group n=41 Participants Control - two or less portions fruit and vegetables/day	High FV Group n=40 Participants 5 portions fruit and vegetables/day 5 portions fruit and vegetables/day: Participants consume \> = 5 portions fruit and veg per day	Total n=81 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	63.2 years STANDARD_DEVIATION 9.1 • n=7 Participants	62.2 years STANDARD_DEVIATION 8.71 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United Kingdom	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

A series of 7-day diet histories were completed by each participant at weeks 0 and 12 in order to assess baseline diet and self-reported compliance with the intervention; average daily FV intake was then hand-counted from these records;

Outcome measures

Outcome measures
Measure	Control n=41 Participants Control -two or fewer portions fruit and vegetables/day	Intervention n=40 Participants 5 portions fruit and vegetables/day 5 portions fruit and vegetables/day: Participants consume \> = 5 portions fruit and veg per day
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);	1.9 Portions per day Standard Deviation 0.5	6.1 Portions per day Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 Weeks

Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane ng/ml

Outcome measures

Outcome measures
Measure	Control n=27 Participants Control -two or fewer portions fruit and vegetables/day	Intervention n=25 Participants 5 portions fruit and vegetables/day 5 portions fruit and vegetables/day: Participants consume \> = 5 portions fruit and veg per day
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane	1.70 ng/ml Interval 1.26 to 2.42	1.83 ng/ml Interval 1.18 to 2.63

SECONDARY outcome

Timeframe: 12 weeks

Plasma vitamin C concentration umol/L

Outcome measures

Outcome measures
Measure	Control n=36 Participants Control -two or fewer portions fruit and vegetables/day	Intervention n=38 Participants 5 portions fruit and vegetables/day 5 portions fruit and vegetables/day: Participants consume \> = 5 portions fruit and veg per day
Biochemical Markers of Nutritional Status Plasma Vitamin C	33.44 umol/l Standard Deviation 21.19	47.64 umol/l Standard Deviation 19.23

Adverse Events

1 Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Michelle McKinley

Queen's University Belfast

Phone: 02890978936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place