Trial Outcomes & Findings for Food Preference Following Bariatric Surgery (NCT NCT03363581)

NCT ID: NCT03363581

Last Updated: 2023-08-08

Results Overview

Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

• Recruitment status: COMPLETED
• Target enrollment: 34 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2023-08-08

Participant Flow

Participant milestones

Measure	Gastric Bypass Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Overall Study STARTED	14	20
Overall Study COMPLETED	14	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Food Preference Following Bariatric Surgery

Baseline characteristics by cohort

Measure	Gastric Bypass n=14 Participants Obese patients due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference	Total n=34 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 7.8 • n=5 Participants	28 years STANDARD_DEVIATION 4.1 • n=7 Participants	39.5 years STANDARD_DEVIATION 5.95 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Ireland	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants
Body weight (kg)	136 kg STANDARD_DEVIATION 23.8 • n=5 Participants	65 kg STANDARD_DEVIATION 5.2 • n=7 Participants	100.5 kg STANDARD_DEVIATION 14.5 • n=5 Participants
Total Food Intake (Lunch Buffet)	6510.3 kJ STANDARD_DEVIATION 1023 • n=5 Participants	800 kJ STANDARD_DEVIATION 50 • n=7 Participants	3655 kJ STANDARD_DEVIATION 536.5 • n=5 Participants
Absolute intake of fat	2617.1 kJ STANDARD_DEVIATION 250 • n=5 Participants	310 kJ STANDARD_DEVIATION 30 • n=7 Participants	1448.5 kJ STANDARD_DEVIATION 265 • n=5 Participants
Absolute intake of carbohydrates	3102.4 kJ STANDARD_DEVIATION 1080 • n=5 Participants	300 kJ STANDARD_DEVIATION 70 • n=7 Participants	1701.2 kJ STANDARD_DEVIATION 575 • n=5 Participants
Absolute intake of protein	833.9 kJ STANDARD_DEVIATION 87.0 • n=5 Participants	190 kJ STANDARD_DEVIATION 15 • n=7 Participants	511.95 kJ STANDARD_DEVIATION 94.5 • n=5 Participants
Absolute intake of sugar	1312.5 kJ STANDARD_DEVIATION 300 • n=5 Participants	180 kJ STANDARD_DEVIATION 30 • n=7 Participants	746.25 kJ STANDARD_DEVIATION 315 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

Outcome measures

Measure	Gastric Bypass n=14 Participants Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Total Food Intake (Lunch Buffet) at 24 Months	2540.1 kJ Standard Deviation 431.0	721 kJ Standard Deviation 201

PRIMARY outcome

Timeframe: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet

Outcome measures

Measure	Gastric Bypass n=14 Participants Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Change in Absolute Intake of Fat	-1549.7 kJ Standard Error 298.9	301 kJ Standard Error 70.1

PRIMARY outcome

Timeframe: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet

Outcome measures

Measure	Gastric Bypass n=14 Participants Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Change in Absolute Intake of Carbohydrates	-2088.6 kJ Standard Error 370.1	280 kJ Standard Error 40.3

PRIMARY outcome

Timeframe: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet

Outcome measures

Measure	Gastric Bypass n=14 Participants Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Change in Absolute Intake of Sugar	-890.7 kJ Standard Error 258.1	160.0 kJ Standard Error 39.8

PRIMARY outcome

Timeframe: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet

Outcome measures

Measure	Gastric Bypass n=14 Participants Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference	Healthy Free-living Individuals n=20 Participants Healthy free-living individuals Food Preference: Buffet meal to assess food preference
Change in Absolute Intake of Protein	-360.7 kJ Standard Error 91.4	140.2 kJ Standard Error 35.2

Adverse Events

Gastric Bypass

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Free-living Individuals

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

Prof Carel le Roux

Imperial College London

Phone: 07970719453

Email: carel.leroux@nhs.net

Results disclosure agreements

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