Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108524
Recruitment Status : Completed
First Posted : April 18, 2005
Results First Posted : December 12, 2013
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus
Obesity
Interventions Behavioral: Low carbohydrate ketogenic diet
Drug: Orlistat
Behavioral: Low-fat diet
Enrollment 146
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Low Carbohydrate Ketogenic Diet Low-Fat Diet Plus Orlistat
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 81 79
Completed 52 61
Not Completed 29 18
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 72 74 146
Hide Baseline Analysis Population Description
160 participants were randomized (81 allocated to LCKD, 79 to Orlistat plus LFD). 14 did not receive the intervention. 33 discontinued the intervention. Out of the 146 participants analyzed, 113 completed the intervention.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
 100.0%
74
 100.0%
146
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 74 participants 146 participants
52.9  (10.2) 52.0  (9.2) 52  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
Female
20
  27.8%
21
  28.4%
41
  28.1%
Male
52
  72.2%
53
  71.6%
105
  71.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 74 participants 146 participants
72 74 146
1.Primary Outcome
Title Change From Baseline in Body Weight at 48 Weeks
Hide Description 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.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
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.
Overall Number of Participants Analyzed 72 74
Mean (95% Confidence Interval)
Unit of Measure: percentage of weight loss
-9.5
(-14.8 to -7.9)
-8.5
(-11.0 to -6.1)
2.Secondary Outcome
Title Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
Hide Description Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
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.
Overall Number of Participants Analyzed 72 74
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-1.91
(-8.14 to 4.33)
-8.29
(-14.06 to -2.52)
3.Secondary Outcome
Title Change From Baseline in Blood Sugar at 48 Weeks
Hide Description Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Time Frame Baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
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.
Overall Number of Participants Analyzed 72 74
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-9.74
(-16.93 to -2.55)
-3.54
(-10.05 to -3.26)
Time Frame 48 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. 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.
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/72 (1.39%)      2/74 (2.70%)    
Gastrointestinal disorders     
gastrointestinal symptoms  [1]  1/72 (1.39%)  1 2/74 (2.70%)  2
Indicates events were collected by systematic assessment
[1]
1 participant discontinued orlistat treatment due to intolerance of gastrointestinal symptoms.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/72 (68.06%)      30/74 (40.54%)    
Gastrointestinal disorders     
constipation  [1]  49/72 (68.06%)  49 30/74 (40.54%)  30
Indicates events were collected by systematic assessment
[1]
constipation
We provided orlistat at no cost. This could have increased dietary adherence, attendance, and/or retention compared with the LCKD and may lead to different results than what might be seen in patients who must pay for orlistat.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William S Yancy, Jr. MD, MHSc
Organization: Durham VAMC
Phone: 919-286-0411 ext 7770
EMail: william.yancy2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00108524     History of Changes
Other Study ID Numbers: CLIN-005-03F
First Submitted: April 15, 2005
First Posted: April 18, 2005
Results First Submitted: September 26, 2013
Results First Posted: December 12, 2013
Last Update Posted: April 17, 2014