None listed
Conditions
Interventions
Participants will be randomised to 1 of 4 treatments of 3 week duration each and crossed over at the end of each 3 weeks to the alternative treatment (for all 4 treatments). Each intervention will be double blind. After each 3 week phase a 1 week washout period, where volunteers return to their regular dietary intake is followed. The test foods are either cream cheese or cheese slices as follows:
1. 1 mini-tub of 40gm cream cheese containing 2.0gm sterol esters each day,
2. 2 serves of 20.5gm ch
Participants will be randomised to 1 of 4 treatments of 3 week duration each and crossed over at the end of each 3 weeks to the alternative treatment (for all 4 treatments). Each intervention will be double blind. After each 3 week phase a 1 week washout period, where volunteers return to their regular dietary intake is followed. The test foods are either cream cheese or cheese slices as follows: 1. 1 mini-tub of 40gm cream cheese containing 2.0gm sterol esters each day, 2. 2 serves of 20.5gm cheese slice containing 2.0gm sterol esters each day, 3. 1 mini-tub of 40gm sterol free cream cheese each day, 4. 2 serves of 20.5gm sterol free cheese slice each day. The test foods are reduced in total fat and volunteers will be required to incorporate the test foods into their existing diet by replacing like foods. This is in anticipation of maintaining energy balance to support weight maintenance throughout the study.
Sponsors
Kraft Foods
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Body Mass Index (BMI) less than 35. Total cholesterol greater than 5.0mmol/L and less than 7.5mmol/L. Triglycerides less than 4.5 mmol/L. Participants currently taking phytosterol fortified products are permissible provided they have a 3 week washout prior to study commencement.
Exclusion criteria
Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions. Participants taking any supplements (eg fish oil) and medications (eg statins/fibrates which could interfere with study parameters. Presence of diabetes (as assessed from medical questionnaire fasting glucose great than 7mmol/L by fingerprick at screening) Known lactose intolerance or dairy allergy. Participation in a study within 30 days of commencement of the study. Weight changes of more than 3kg over last 3 months. History of Cardiovascular disease.
Outcome results
None listed