None listed
Conditions
Brief summary
This study will investigate the molecular mechanisms by which a fruit and vegetable supplement modulates systemic inflammation. Based on previous studies utilising fruit and vegetable supplements and our own fruit and vegetable withdrawal study, we hypothesise that the extract will modify systemic inflammatory pathways, including NF-kappaB, AMPK, MAPK, PPARalpha/gamma and TLR2/4, among others. In addition, various proteins associated with inflammation, lipid metabolism and insulin resistance will be improved. Determining whether the supplement is an effective treatment for reducing systemic inflammation in obesity and identifying the mechanisms involved may assist in reducing the risk of chronic diseases, including CVD and diabetes. This is critically important for reducing the burden of disease in this subgroup of the population for whom weight management/ weight loss has not been achievable.
Interventions
An 8-week double-blinded, parallel, placebo-controlled RCT to examine the effects of a fruit and vegetable supplement vs placebo (3 capsules twice daily with meals) on gene expression of inflammatory pathways, systemic inflammation, lipid metabolism, insulin resistance, CVD risk and plasma antioxidant levels, in obese adults aged 50 years or older.
Participants will be screened for study eligibility, including medical history, medication usage, blood pressure and blood chemistry. Blood samples
An 8-week double-blinded, parallel, placebo-controlled RCT to examine the effects of a fruit and vegetable supplement vs placebo (3 capsules twice daily with meals) on gene expression of inflammatory pathways, systemic inflammation, lipid metabolism, insulin resistance, CVD risk and plasma antioxidant levels, in obese adults aged 50 years or older. Participants will be screened for study eligibility, including medical history, medication usage, blood pressure and blood chemistry. Blood samples will be obtained by venepuncture by trained personnel for determination of full blood count, liver function tests and electrolytes, urea, creatinine. Once the screening blood test results have been received, eligible participants will be booked in and given advice on how to restrict fruit and vegetable intake to no more than three serves per day from two weeks prior to visit 1. Visit 1: This is the study randomisation visit. Participants will arrive at the HMRI clinic after a 12-hour overnight fast. They will have a fasting venous blood sample collected, and their weight and waist circumference measured. Blood samples will be collected, and blood pressure and pulse wave velocity (arterial stiffness) will be recorded. Participants will complete quality of life, food frequency and 24-hour food recall questionnaires, and medication use and medical history will be checked. Body composition will be measured by full body dual-energy x-ray absorptiometry (DEXA). At the completion of this visit, participants will receive capsules: fruit and vegetable supplement, or placebo. Participants will be instructed to take 3 capsules twice daily with meals. Participants will be advised to continue their usual diet, noting that they will need to continue to restrict fruit and vegetable intake to no more than three serves each day for the study duration. Subjects who have a higher regular fruit and vegetable intake will receive advice on suitable substitutions, to assist them with adherence. Participants will also receive a pill diary to record supplements use daily for the 8 weeks. Phone call 1, 2 and 3: During the intervention period, subjects will be telephoned fortnightly for motivational purposes, to collect information on compliance with the supplements and dietary restriction, and to establish whether any side effects have been experienced. Visit 2: Visit 2 will be conducted eight weeks after visit 1. Participants will arrive at the HMRI clinic after a 12-hour overnight fast. They will have a fasting venous blood sample collected, and their weight and waist circumference measured. Blood pressure and pulse wave velocity (arterial stiffness) will be recorded. Body composition will be measured by a full body dual-energy x-ray absorptiometry (DEXA) scan. Participants will complete quality of life and 24-hour food recall questionnaires, and medication use and medical history will be checked. Participants will return any unused capsules and their completed pill diary, and will be instructed to resume their usual diet. Investigational Product The active supplement capsules used in this study contain mostly fruit and vegetable juice powder and pulp, resembling fine, brown, granular powder in an opaque gelatine capsule. The supplements are made from fruits, vegetables and other ingredients intended for human consumption, commonly consumed by humans for many years. The fruits and vegetables are cleaned, washed and chilled before juicing. The chilled juices are dried using a proprietary drying process. Ingredients: Fruit juice powder and pulp from: Acerola cherry, apple, artichoke, beet, bilberry, blackberry, black currant, blueberry, broccoli, cabbage, carrot, cocoa, concord grape, cranberry, date, elderberry, garlic, grape seed extract, green tea, kale, oat bran, orange, papaya, parsley, peach, pineapple, pomegranate, raspberry, red currant, rice bran, spinach, tomato. Other ingredients: Gelatin, glucomannan, bromelain, calcium ascorbate, citrus pectin, beetroot powder, citrus bioflavonoids from tangerine, mixed tocoperhols, calcium carbonate, garlic powder, Spirulina pacifica, magnesium oxide, natural mixed carotenoids, natural enzyme blend, papain, sugar beet fibre, oat bran fibre, date fibre, prune fibre, rice bran, silicon dioxide, Lactobacillus acidophilus, vegetable derived magnesium stearate, folic acid. Clinical Test Product Representative Nutritional Values, per 6 capsules daily dose Nutrient beta-carotene 3.4 mg/ 5835 IU Vitamin E 2.8 mg/ 4 IU Vitamin C 300mcg Folate 200mcg
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Males and females aged >=50 years; obese (BMI >=30kg/m2); absence / irregular menses in females; non-smokers.
Exclusion criteria
Unwilling or unable to limit intake of fruit and vegetables to no more than 3 serves per day; dietary or nutritional supplement use within the previous 4 weeks; current smokers; chronic excessive alcohol consumption; current participation in a weight management program or actively attempting to lose weight; current use of any medication known to significantly influence inflammation and allergy to fruit or vegetables.
Outcome results
None listed