None listed
Conditions
Brief summary
The study comprises a cross sectional, case-control study comparing the long term health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids, ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations. Pre-study power calculations have been conservatively based on between group differences in faecal butyrate, with medium effect size (d=0.5) and 80% power. Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis. Faecal biochemistry (SCFA, bile acids, ammonia, phenol, total moisture) will be determined using gas chromatography (GC) and high performance liquid chromatography (HPLC) methods. Serum samples will be analysed for SCFA, TMAO and BCAA. Food group, and dietary fibre intake will be analysed using SPSS v22.0 (IBM Corporation, 2013) with between groups and within groups analysis being performed. Data obtained from experiment three will be analysed using SPSS v22.0 (IBM Corporation, 2013) and PRIMER-7 (Primer-E, 2015). Outcome variables will be compared to macronutrient intake as continuous variables using general linear modelling. Analysis of data in this manner will provide estimations of risk for changes in outcome variables for changing carbohydrate, fat and protein intake. The study will provide significant information to public health educators in relation to Paleolithic and AGHE dietary patterns. The study will provide a significant contribution to the understanding of how total long term dietary patterns, inclusive and exclusive of grains and legumes contribute to the risks of future development of non-infectious bowel disease, diabetes and cardiovascular disease.
Interventions
The study comprises a cross sectional, case-control study comparing the long term
health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. The Paleolithic diet is based on fruits, vegetables, meat, eggs and nuts and excludes grains, legumes and dairy foods which form part of the evidence based Australian Guide to Healthy Eating guidelines. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids,ammonia and phe
The study comprises a cross sectional, case-control study comparing the long term health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. The Paleolithic diet is based on fruits, vegetables, meat, eggs and nuts and excludes grains, legumes and dairy foods which form part of the evidence based Australian Guide to Healthy Eating guidelines. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids,ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations. Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis.
Sponsors
Edith Cowan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
The study will recruit men and women who meet the following inclusion criteria; - Men and women aged 18-70 years; - Have been following the Paleolithic diet or high carbohydrate diet for greater than 1year; - Willing to complete a 3-day WDR; - Willing to provide blood, urine and stool sample; - Non-smoker; - Not participating in any other studies; - Have BMI <30 kg/m2
Exclusion criteria
Subjects will be excluded if they: - Have taken antibiotics in the last six months; - Have any digestive disorder which may affect nutrient absorption and gastrointestinal motility such as Coeliac disease, Irritable Bowel Disease/Disorder, ulcerative colitis or Crohn’s Disease; - Have had any surgery involving the gastro-intestinal tract; - Have diabetes or diagnosed metabolic syndrome; - Are taking any antihypertensives or lipid lowering medication; - Have or have had any cardiovascular events or diagnosed cardiovascular disease. Subjects following a Paleolithic diet that consume >1 serve equivalent per day of grains/legumes will also be excluded from participating.
Outcome results
None listed