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

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.

Conditions

• Obesity
• Cognitive Change

Interventions

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.

Sponsors & Collaborators

• Federal Stare Budgetary Scientific Institution, Mental Health Research Center

  collaborator OTHER

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

  lead OTHER

Principal Investigators

• Antonina V. Starodubova, MD, Full PhD · Deputy Director of the Federal Research Centre of Nutrition, Biotechnology and Food Safety

• Yurgita R. Varaeva, MD, MRes · Research Fellow of the Federal research Centre of Nutrition, Biotechnology and Food Safety

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-09

Primary Completion

2023-06-30

Completion

2023-12-30

Countries

• Russia

Study Locations