None listed
Conditions
Brief summary
We have previously developed a coconut yogurt enriched with turmeric and coffee bean extracts known for their benefits in metabolic disorders and chronic inflammatory diseases. In the proposed study we aim to assess the developed yoghurt for its anti-inflammatory and metabolic effects in post-menopausal women after consuming the yogurt for 2 weeks. Postmenopause is associated with higher dyslipidemia, inflammation, and unbalanced oxidative status when compared to non-menopausal women. The higher inflammatory, oxidative and metabolic status in post-menopausal women increase their risk of metabolic disorders such as cardiovascular disease.
Interventions
Acute study: stage 1
First visit
• Eligible participants will sign a consent form and complete a dietary questionnaire (24-hour food recall), medical history and ethnicity questionnaire. Participants will also be asked to complete questionnaire to assess their physical activity using the International Physical Activity Questionnaire (IPAQ) short.
• Participants will have their anthropometric measurements and blood pressure taken followed by a baseline venous blood sample (15 ml) for measurement
Acute study: stage 1 First visit • Eligible participants will sign a consent form and complete a dietary questionnaire (24-hour food recall), medical history and ethnicity questionnaire. Participants will also be asked to complete questionnaire to assess their physical activity using the International Physical Activity Questionnaire (IPAQ) short. • Participants will have their anthropometric measurements and blood pressure taken followed by a baseline venous blood sample (15 ml) for measurement of study outcomes • Participants will be asked to consume the yoghurt plus breakfast on site. A venous blood sample (6 ml) will be taken at 30 min, 60 min, 120 min, 180 and 240 min post yoghurt consumption Second visit • After at least 7 days washout period, participants will be asked to consume the other yoghurt (in a crossover) plus breakfast on site. Venous blood samples (6ml) will be taken at baseline, 30 min, 60 min, 120 min, 180 and 240 min post yoghurt consumption Chronic study: Stage 2 Stage 2 will only occur if the expected results from stage 1 are achieved. Participant from the stage 1 study will be invited to participate in stage 2. However, the study will also be advertised to the general public. First visit • Eligible participants will sign a consent form and complete a dietary questionnaire (24-hour food recall), medical history and ethnicity questionnaire. Participants will also be asked to complete questionnaire to assess their physical activity using the International Physical Activity Questionnaire (IPAQ) short. • Participants will have their anthropometric measurements and blood pressure taken followed by a venous blood sample (15 ml) collected for measurement of study outcomes • At the end of the visit, participants will be given 1- weeks’ worth of yoghurt to take home and begin consuming daily after a 1-week washout period. Another 1- weeks’ worth of yoghurt will be provided to the participants during week-2, to consume daily (for a total of 14 days of yoghurt consumption). Second visit - After 21 days, participants will be asked to complete another physical activity & dietary questionnaire • Participants will have their anthropometric measurements and blood pressure taken, followed by a venous blood sample (15 ml) for study outcome measurements after an overnight fast. Arm 1 is a coconut yoghurt containing turmeric and coffee extract. Arm 2 will be control yogurt. All study food will be prepared/developed a food grade accredited facility.
Sponsors
Riddet Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Women who have been menopausal for at least a year (defined as more than 12 months of consecutive amenorrhea) • Aged between 45 and 65 • BMI between 25-40Kg/m2
Exclusion criteria
• Cigarette smokers • Are on hormone replacement therapy • Dairy intolerant • Suffering from inflammatory illnesses including cancer, HIV/Aids or inflammatory bowel disease • Recently donated blood or have fear of needles • Are dieting or have any eating disorders and have lost more than 20 Kg weight in the last 6 months • Have dislike, intolerance or allergy to yoghurt, coconut, coffee or curry • Have a history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerosis • Have a history of cancer, diabetes, hypertension, high cholesterol • Have a history of gastrointestinal disorder or liver disease
Outcome results
None listed