Trial reportCardiovascular diabetology2009
Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study.
Trial report in Cardiovascular diabetology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 104 papers, 13 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes
Who cites it
104 citing papers in PubMed, 13 syntheses or guidelines pooled it, 274 citations in OpenAlex.
- Effects of carbohydrate-restricted diets and macronutrient replacements on cardiovascular health and body composition in adults: a meta-analysis of randomized trials.The American journal of clinical nutrition · 2025Pooled it
- Comparative effects of different macronutrient compositions for type 2 diabetes management: a systematic review and network meta-analysis of randomized trials.Journal of health, population, and nutrition · 2025Pooled it
- Efficacy of a High-Protein Diet to Lower Glycemic Levels in Type 2 Diabetes Mellitus: A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Pooled it
- Low-carbohydrate versus balanced-carbohydrate diets for reducing weight and cardiovascular risk.The Cochrane database of systematic reviews · 2022Pooled it
- Pooled it
- Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data.BMJ (Clinical research ed.) · 2021Pooled it
- Impact of different dietary approaches on blood lipid control in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis.European journal of epidemiology · 2019Pooled it
- Influence of Paleolithic diet on anthropometric markers in chronic diseases: systematic review and meta-analysis.Nutrition journal · 2019Pooled it
- Effects of a Paleolithic Diet on Cardiovascular Disease Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Advances in nutrition (Bethesda, Md.) · 2019Pooled it
- Paleolithic nutrition for metabolic syndrome: systematic review and meta-analysis.The American journal of clinical nutrition · 2015Pooled it
- Transtheoretical model stages of change for dietary and physical exercise modification in weight loss management for overweight and obese adults.The Cochrane database of systematic reviews · 2014Pooled it
- Macronutrients, food groups, and eating patterns in the management of diabetes: a systematic review of the literature, 2010.Diabetes care · 2012Pooled it
- Randomised crossover controlled trial of dietary interventions for glycaemic control when body weight is kept stable.Journal of nutritional science · 2025Trial
- Randomised controlled trial of lifestyle interventions for abdominal obesity in primary health care.Primary health care research & development · 2024Trial
- Trial
- Diet-induced weight loss alters hepatic glucocorticoid metabolism in type 2 diabetes mellitus.European journal of endocrinology · 2020Trial
- Postprandial levels of GLP-1, GIP and glucagon after 2 years of weight loss with a Paleolithic diet: a randomised controlled trial in healthy obese women.European journal of endocrinology · 2019Trial
- A Paleolithic diet lowers resistant starch intake but does not affect serum trimethylamine-N-oxide concentrations in healthy women.The British journal of nutrition · 2019Trial
- Exercise Training Adds Cardiometabolic Benefits of a Paleolithic Diet in Type 2 Diabetes Mellitus.Journal of the American Heart Association · 2019Trial
44 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOur aim was to compare the effects of a Paleolithic ('Old Stone Age') diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin.
methodsIn a randomized cross-over study, 13 patients with type 2 diabetes, 3 women and 10 men, were instructed to eat a Paleolithic diet based on lean meat, fish, fruits, vegetables, root vegetables, eggs and nuts; and a Diabetes diet designed in accordance with dietary guidelines during two consecutive 3-month periods. Outcome variables included changes in weight, waist circumference, serum lipids, C-reactive protein, blood pressure, glycated haemoglobin (HbA1c), and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test. Dietary intake was evaluated by use of 4-day weighed food records.
resultsStudy participants had on average a diabetes duration of 9 years, a mean HbA1c of 6,6% units by Mono-S standard and were usually treated with metformin alone (3 subjects) or metformin in combination with a sulfonylurea (3 subjects) or a thiazolidinedione (3 subjects). Mean average dose of metformin was 1031 mg per day. Compared to the diabetes diet, the Paleolithic diet resulted in lower mean values of HbA1c (-0.4% units, p = 0.01), triacylglycerol (-0.4 mmol/L, p = 0.003), diastolic blood pressure (-4 mmHg, p = 0.03), weight (-3 kg, p = 0.01), BMI (-1 kg/m2, p = 0.04) and waist circumference (-4 cm, p = 0.02), and higher mean values of high density lipoprotein cholesterol (+0.08 mmol/L, p = 0.03). The Paleolithic diet was mainly lower in cereals and dairy products, and higher in fruits, vegetables, meat and eggs, as compared with the Diabetes diet. Further, the Paleolithic diet was lower in total energy, energy density, carbohydrate, dietary glycemic load, saturated fatty acids and calcium, and higher in unsaturated fatty acids, dietary cholesterol and several vitamins. Dietary GI was slightly lower in the Paleolithic diet (GI = 50) than in the Diabetic diet (GI = 55).
conclusionOver a 3-month study period, a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.