Trial Outcomes & Findings for A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss (NCT NCT00108524)

NCT ID: NCT00108524

Last Updated: 2014-04-17

Results Overview

Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: baseline and 48 weeks
• Results posted on: 2014-04-17

Participant Flow

Participants were recruited from outpatient clinics affiliated with the Department of Veterans Affairs Medical Center in Durham, North Carolina, between April 2005 and October 2006.

18-70yo,BMI 27-30+obesity-related disease or BMI>30 regardless of comorbidity. Excluded:weight loss in <30 days;pregnant,breastfeeding,DM-1;unstable heart disease or psych illness,dementia,substance abuse;HTN >160/100; creatinine>1.5men,>1.3women; HemA1c>11%; triglyceride>600; LDL-C>190. Not considered enrolled if not told group assignment (n=14).

Participant milestones

Measure	Low Carbohydrate Ketogenic Diet Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished.	Low-Fat Diet Plus Orlistat Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily. Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (\<30% of daily energy), saturated fat (\<10% of daily energy), cholesterol (\<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly.
Overall Study STARTED	81	79
Overall Study COMPLETED	52	61
Overall Study NOT COMPLETED	29	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

Baseline characteristics by cohort

Measure	Arm 1 n=72 Participants Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished.	Arm 2 n=74 Participants Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily. Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (\<30% of daily energy), saturated fat (\<10% of daily energy), cholesterol (\<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly.	Total n=146 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
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	74 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.9 years STANDARD_DEVIATION 10.2 • n=5 Participants	52.0 years STANDARD_DEVIATION 9.2 • n=7 Participants	52 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	53 Participants n=7 Participants	105 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	74 participants n=7 Participants	146 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 48 weeks

Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.

Outcome measures

Measure	Arm 1 n=72 Participants Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.	Arm 2 n=74 Participants Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Change From Baseline in Body Weight at 48 Weeks	-9.5 percentage of weight loss Interval -14.8 to -7.9	-8.5 percentage of weight loss Interval -11.0 to -6.1

SECONDARY outcome

Timeframe: baseline and 48 weeks

Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.

Outcome measures

Measure	Arm 1 n=72 Participants Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.	Arm 2 n=74 Participants Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks	-1.91 mg/dL Interval -8.14 to 4.33	-8.29 mg/dL Interval -14.06 to -2.52

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.

Outcome measures

Measure	Arm 1 n=72 Participants Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.	Arm 2 n=74 Participants Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Change From Baseline in Blood Sugar at 48 Weeks	-9.74 mg/dL Interval -16.93 to -2.55	-3.54 mg/dL Interval -10.05 to -3.26

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Arm 2

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=72 participants at risk Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.	Arm 2 n=74 participants at risk Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Gastrointestinal disorders gastrointestinal symptoms	1.4% 1/72 • Number of events 1 • 48 weeks The O + LFD participants reported gastrointestinal effects more frequently than the LCKD participants, occurring predominantly after dietary indiscretions. The LCKD had its own gastrointestinal adverse effect, constipation, in most cases resolving by increasing fluid and dietary fiber intake and/or adding a fiber supplement or stool softener.	2.7% 2/74 • Number of events 2 • 48 weeks The O + LFD participants reported gastrointestinal effects more frequently than the LCKD participants, occurring predominantly after dietary indiscretions. The LCKD had its own gastrointestinal adverse effect, constipation, in most cases resolving by increasing fluid and dietary fiber intake and/or adding a fiber supplement or stool softener.

Other adverse events

Measure	Arm 1 n=72 participants at risk Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.	Arm 2 n=74 participants at risk Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Gastrointestinal disorders constipation	68.1% 49/72 • Number of events 49 • 48 weeks The O + LFD participants reported gastrointestinal effects more frequently than the LCKD participants, occurring predominantly after dietary indiscretions. The LCKD had its own gastrointestinal adverse effect, constipation, in most cases resolving by increasing fluid and dietary fiber intake and/or adding a fiber supplement or stool softener.	40.5% 30/74 • Number of events 30 • 48 weeks The O + LFD participants reported gastrointestinal effects more frequently than the LCKD participants, occurring predominantly after dietary indiscretions. The LCKD had its own gastrointestinal adverse effect, constipation, in most cases resolving by increasing fluid and dietary fiber intake and/or adding a fiber supplement or stool softener.

Additional Information

William S Yancy, Jr. MD, MHSc

Durham VAMC

Phone: 919-286-0411

Email: william.yancy2@va.gov

Results disclosure agreements

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