NCT05841173

Effects of Weight Loss Management on Cognitive Function in Elderly Women With Obesity

Effects of Weight Loss Management on Cognitive Function in Elderly Obese Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Academic / Other
• Sex: Female
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

According to studies, the risk of cerebrovascular disease and cognitive decline are associated with age-related changes. In addition, there is data suggesting a relationship between the progression of this pathology and the presence of obesity and associated metabolic disorders. According to to some research, weight loss associated with cognitive function decline. In this regard, the development of effective, applicable in real clinical practice methods of non-drug treatment and prevention of cerebrovascular disorders and age-related cognitive decline in people with obesity and metabolic disorders, who are at high risk, seems to be extremely relevant. The main goal of the study is to compare the effectiveness of various weight loss approaches and to study their effects on the cognitive functions of elderly obesity women.

Detailed description

The high prevalence of comorbid pathology characterised the elderly and senile population. Particularly, comorbid condition is often based on obesity. Also, an important characteristic of the elderly and senile age is the development of age-related cognitive deficit and progressive decline in cognitive functions, that is detected in 60.8% of people over 65 years old in Russia according to the EVKALIPT study. The prevalence of obesity in the Russian population reaches 40% among the elderly population. According to studies, the presence of obesity is "paradoxically" associated with less progression of cognitive function loss, and the risk reduction in some populations reaches 40%. However, the sarcopenic obesity is an independent predictor of cognitive impairment in the elderly. Consequently, the therapy of obesity in elderly and senile population faces two important aspects: the risk of muscle loss and the development of sarcopenia and progressive cognitive decline. The described features of this age group are consistent with the well-known "obesity paradox", in which overweight and obesity are associated with longer life expectancy. The risk of muscle mass reduction and cognitive functions decrease determines the formation of a specialised approach to obesity management in older population. Thus, the setting of softer and longer-term goals with a gradual decrease in body weight is typical. Studies have considered the use of various interventions, so far the combination of diet with exercise has proven effectiveness in muscle mass protection. At the same time, regular exercises reliably protect from cognitive decline. Thereby, the combination of diet and physical activity is considered as a suitable approach to obesity management in the elderly. Recently, there have also been a number of studies evaluating the effectiveness of the ketogenic diet. This diet pattern is reliably effective in body weight reduction, skeletal muscle mass maintenance, and adipose tissue metabolism improvement in the elderly . Also, the neuroprotective effects of the ketogenic diet have been confirmed by meta-analyses and have made it possible to include it in current guidelines for the prevention and treatment of cognitive impairment. However, the high frequency of negative effects and the associated low adherence limit the possibilities of using this diet, which led to the development of exogenous ketones that allow reaching the levels of blood ketone bodies associated with neuroprotective properties (0.2-0.5 mmol/l) with better portability. The main goal of the study is to compare the effectiveness of various weight loss approaches and to study their effects on the cognitive functions of elderly obesity women.

Conditions

• Obesity
• Cognitive Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	"PanTrek"	The intervention is represented by the investigational product "PanTrek", shots with liquid, 25 ml each (TU 10.89.19-01-44850857-2020). The composition of the product "PanTrek" (per 1 dose): * Ginseng dry extract (Panax ginseng Meyer) all parts of the plant - 125 mg (the amount of ginsenosides in one vial is 9.0 mg ± 3.5 mg); * Melissa officinalis dry extract (Melissa officinalis L) all parts of the plant - 340 mg (the amount of hydroxycinnamic acids is 19.50 mg / vial ± 10% in one vial); * Apple juice concentrated 2.5% - 7,5 g; * Potassium beta-hydroxybutyrate - 4,5 g; * Magnesium beta-hydroxybutyrate - 500 mg; * E211 sodium benzoate - no more than 5 mg; * E202 Potassium sorbate - no more than 3,6 mg; * Water purified - up to 25 ml. The product has registered as diet supplement in the Unified Register of Certificates of State Registration N RU.77.99.11.003.R.001152.04.21 from 05.04.2021.
BEHAVIORAL	Physical Trainings	Physical activity is represented by 2 workouts lasting 45 minutes per week on an antigravity treadmill Alter-G M320 (AlterG, USA) and 2 sessions of reoxygenation lasting 30 minutes on a normobaric hypoxic therapy device ReOxy (Bitmos GmbH, Germany).
OTHER	Placebo	The placebo is represented by concentrated apple juice 2.5% - 7.5 g, potassium chloride - 2.405 g, MgCl2 - 0.382 g, sodium benzoate (E211) - 5 mg and potassium sorbate (E202) - 3.6 mg, brought to 25 ml of distilled water.
BEHAVIORAL	Diet	The studied diet is a low-calorie diet with an average energy value of 1730.16 kcal / day and a certain chemical composition (proteins - 108.80 g / day, fats - 68.10 g / day, carbohydrates - 162.60 g / day), including the main groups products (meat and poultry dishes, fish dishes, dairy products, cereals, vegetables and fruits). On average, 0.96-1.05 g of protein accounted for 1 kg of body weight of the subjects.

Timeline

• Start date: 2022-01-09
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2023-05-03
• Last updated: 2023-05-06

Locations

1 site across 1 country: Russia