None listed
Conditions
Brief summary
Reduced carbohydrate diets offer benefits for the prevention and adjunct treatment of health conditions including; neurological disorders, cancer, obesity, diabetes and other conditions on the spectrum of metabolic syndrome. They are increasingly popular for mainstream and athletic use for weight-loss and maintenance and have been demonstrated to improve satiety and reduce hunger. But adaptation from a standard diet to one low in carbohydrates can cause various unpleasant symptoms, referred to in common parlance as ‘keto-flu’. These symptoms of carbohydrate restriction are assumed to provide a barrier to the use of, and compliance with low carbohydrate diets. However, these early-induction symptoms have not been well described in the scientific literature. So, at this time, it is not clear whether symptoms are related solely to keto-induction (i.e. in very low carbohydrate ketogenic diets) or are more generally, symptoms of carbohydrate withdrawal. Outcomes from ketogenic and non-ketogenic lower carbohydrate diets are likely to be similar and the degree to which people experience symptoms of carbohydrate withdrawal is also likely to influence compliance. For many, it may not be necessary to restrict carbohydrate to the degree necessary to achieve ketosis, especially if the symptoms resulting from extreme carbohydrate restriction are disproportionate to the beneficial outcomes from the diet. This has not been investigated and this study will seek to address this important clinical topic Study Hypothesis: A moderate restriction of carbohydrate results in fewer symptoms of dietary induction and greater tolerance and adherence to diet, with comparable results for cardiometabolic outcomes when compared to more extreme carbohydrate restriction.
Interventions
The intervention is a dietary one. In a three-armed, controlled trial, participants will be provided a dietary plan to match their habitual calorie intake (as determined by a one-week lead in period), but modified to one of three reduced carbohydrate diets; 5% calories from carbohydrate, 15% calories from carbohydrate, and 25% calories from carbohydrate. Guidelines will be provided for protein intake which will be standardised to 1.4g of protein per kilogram of bodyweight for each participant, w
The intervention is a dietary one. In a three-armed, controlled trial, participants will be provided a dietary plan to match their habitual calorie intake (as determined by a one-week lead in period), but modified to one of three reduced carbohydrate diets; 5% calories from carbohydrate, 15% calories from carbohydrate, and 25% calories from carbohydrate. Guidelines will be provided for protein intake which will be standardised to 1.4g of protein per kilogram of bodyweight for each participant, with fat making up the remainder of the calories allotted. The diet plan will be provided as a written plan, prepared by Cliff Harvey, a registered clinical nutritionist of 19 years experience and Caryn Zinn, a registered dietician of twenty years experience. The plan will include general nutritional guidelines for health, foods to be included and excluded in the diet and a menu plan tailored towards each participant and including three meals with portions determined by their calorie and macronutrient allotment. Two workshops will also be provided (by C.H) to provide additional information and support and to ensure participants understand the diet. These workshops will be provided in-person at AUT University for those able to attend and will also be broadcast live via webstream for those unable to attend in person. The workshops will be one hour in duration and will be conducted before the commencement of the trial. Throughout the intervention, participants will have access to the aforementioned practitioners to ask questions. The diet will be prescribed once for a 12-week trial. Information will be provided at AUT Millennium, 17 Antares Place, Rosedale, Auckland, 0632, New Zealand. As a free-living study, participants will be undertaking the diet in their own life environment. Throughout the study participants will have access to the practititioners (C.H and C.Z) via email, and telephone during business hours. Adherence will be monitored via online and app-based food diary (Fat Secret Pro).
Sponsors
AUT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Non-obese, non-diabetic, between the ages of 25 and 49.
Exclusion criteria
BMI <19 or >30, diagnosed metabolic condition such as diabetes, or cardiovascular disease, chronic kidney or liver disease. Pregnancy or breastfeeding. Habitual intake of >40% calories from carbohydrate.
Outcome results
None listed