scholarly journals Trial Protocol: Randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking

Trials ◽  
2010 ◽  
Vol 11 (1) ◽  
Author(s):  
Deborah Lycett ◽  
Peter Hajek ◽  
Paul Aveyard
Keyword(s):  
Weight Gain ◽  
Randomised Controlled Trial ◽  
Dietary Restriction ◽  
Controlled Trial ◽  
Trial Protocol ◽  
Very Low Calorie Diet ◽  
Low Calorie ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Randomised Controlled

scholarly journals Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031431
Author(s):  
Simon Birk Kjær Jensen ◽  
Julie Rehné Lundgren ◽  
Charlotte Janus ◽  
Christian Rimer Juhl ◽  
Lisa Møller Olsen ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Good Clinical Practice ◽  
Study Groups ◽  
Very Low Calorie Diet ◽  
Low Calorie ◽  
Low Calorie Diet ◽  
Calorie Diet

IntroductionThe success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.Methods and analysisThis is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.Ethics and disseminationThe trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.Trial registration number2015-005585-32

Controlled trial of the metabolic effects of a very-low-calorie diet: short- and long-term effects

1990 ◽  
Vol 51 (2) ◽  
pp. 167-172 ◽  
Author(s):  
G D Foster ◽  
T A Wadden ◽  
I D Feurer ◽  
A S Jennings ◽  
A J Stunkard ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Metabolic Effects ◽  
Long Term Effects ◽  
Very Low Calorie Diet ◽  
Low Calorie ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Short And Long Term

scholarly journals A randomised controlled trial of innovative specialised meat product for patients with cardiovascular and metabolic disorders

10.5219/1298 ◽  
2020 ◽  
Vol 14 ◽  
pp. 458-464
Author(s):  
Irina Chernukha ◽  
Elena Kotenkova
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Meat Product ◽  
Meat Products ◽  
Density Lipoprotein ◽  
Control Group ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Randomised Controlled ◽  
Experimental Group

Cardiovascular diseases remain one of the leading causes of death globally. A lot of dietary patterns for CVD prevention have been proposed, but special attention is paid to functional foods. Bioactive proteins and peptides from animal sources are also considered tools for the prevention of CVDs. Here, 40 overweight or obese adult men and women aged between 61 and 66 years, with a body-mass index between 28 and 61 kg.m-2, were enrolled into a randomised controlled trial of new meat products for specialised nutrition. Participants in the control group (n = 20) consumed a standard hyponatric low-calorie diet for 28-30 days (10 days inpatient and 18-20 days outpatient), and in the experimental group – a low-calorie diet and 100g developed meat product (ratio of the porcine aorta to hearts 1:3) per day. Total cholesterol, triglyceride, cholesterol low-density lipoprotein, and cholesterol high-density lipoprotein levels were measured in the serum; from this, the atherogenic index was calculated. The positive effect of developed meat products on the serum lipid profile of patients during the trial was mild but noticeable. A significant reduction in cholesterol levels was noticed in the experimental group, by 18.2% and 14.0% after 7 – 10 and 28 – 30 days, respectively, while the cholesterol level in the control group returned to its original level after 28 – 30 days of dieting. The difference between the control and experimental groups was not significant, while data in the percentiles were. Therefore, it is more preferable to use a developed product as a component in diet therapy for hyperlipidaemic humans for over 28 – 30 days. Pronounced effects of the product could be linked to the unique proteome and peptidome of heart and aorta tissues based on organ-specific gene expression and the presence of tissue-specific substances.

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