None listed
Conditions
Brief summary
Residents of low and middle income countries often suffer from compromised nutritional status because of the sub-optimal water and sanitation setting which leads to repeated exposure to germs from the environment. Exposure to these germs can lead to a gut pathology syndrome, comprising the following: > Damage to the lining of the gut; > Nutrient malabsorption; > ‘Translocation’ or movement of bacteria across the lining of the gut; > Dysbiosis (disturbance of gut bacteria); and > Inflammation. The situation is more serious for immune-compromised individuals such as people living with HIV. Application of a cost-effective intervention that will augment traditional anti-retroviral therapy by repairing the damaged gut, facilitating increased absorption of nutrients, and improving HIV-related immunity will be a welcome adjunct therapy in this priority population. The anticipated benefit of adding resistant starch to HIV-treatment regimens is based on previous observations of favourable effects. Study hypotheses: That adding resistant starch to the normal diet for 2 weeks will lead to improvements in the colon and HIV-related immunity and will be deemed tolerable by study participants.
Interventions
Feasibility pilot study comprising quantitative and qualitative sub-studies.
Quantitative:
Randomized two-by-two double crossover design, single-blinded feeding trial.
A dosage of 40 grams/day of resistant starch will be fed to participants as the 'study intervention'. Forty grams of resistant starch will be added to study foods as 95 grams of High Amylose Maize Starch (HAMS), the commercial food ingredient to be used. HAMS includes both digestible and non-digestible (resistant) fractions and w
Feasibility pilot study comprising quantitative and qualitative sub-studies. Quantitative: Randomized two-by-two double crossover design, single-blinded feeding trial. A dosage of 40 grams/day of resistant starch will be fed to participants as the 'study intervention'. Forty grams of resistant starch will be added to study foods as 95 grams of High Amylose Maize Starch (HAMS), the commercial food ingredient to be used. HAMS includes both digestible and non-digestible (resistant) fractions and will be incorporated into a study food of either flat bread or rice pudding, to be decided following palatability testing. A 'control intervention' of cornstarch will be used and is detailed below under 'Comparator / control treatment.' In phase 1 of this crossover trial, participants will consume study foods incorporating the randomly assigned intervention on a daily basis for a 2 week period in addition to their habitual diet. All participants will then consume their habitual diet only for a 2 week period during the ‘washout period’ when outcome measures are expected to return to baseline (day 0) values. After the washout period, participants will cross over and consume study foods incorporating the other intervention on a daily basis for 2 weeks in addition to their habitual diet in phase 2. A further 2 week washout period will then be applied to all participants after which they will be randomized again to determine which study food will be consumed first in the second crossover using the same two study foods. The same crossover pattern as the first crossover will then apply but it will be based on this second randomization step to determine which study food is consumed first. The study food interventions will be prepared and administered by the Principal Investigator who is a qualified dietitian and university doctoral student in conjunction with the Indian Field Assistant. The study foods will be delivered to the home of the participants for consumption daily during the intervention periods. In some circumstances, where it is more convenient for participants, the study food intervention will be provided at the HIV/ART clinic. Participants will be asked to consume the study food under observation by these study staff as a measure to encourage compliance. Any leftover portion not consumed will be weighed. Qualitative: Participants will also participate in 2 semi-structured interviews (individual or focus group) re: factors affecting compliance with the feeding study and dietary resistant starch intervention including perceptions about participation, study food, palatability and tolerability, adherence and side effects. Individual or focus group interviews will be conducted at the HIV clinic whenever possible. When not possible, interviews will be conducted at the home of the participant or another convenient location nominated by the participant. Interviews will be attended by a 2 person interview team where possible. The semi-structured interviews will be conducted immediately before the phase 1 intervention commences at baseline (day 0), at the end of the phase 2 intervention of the first crossover at day 43 and at the end of the final washout period of the second crossover period at day 112.
Sponsors
Flinders University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.) HIV-positive adults aged 18 years or over on Anti Retroviral Therapy (ART); 2.) CD4+ T cell count more than 200 cells/mm3; 3.) No antibiotic usage within last 6 weeks.
Exclusion criteria
1.) Co-morbidities affecting the gastrointestinal tract such as Crohn’s Disease, Ulcerative Colitis. 2.) Current participation in other interventional studies; 3.) Pregnant or breastfeeding.
Outcome results
None listed