Effects of Weight Loss Management on Cognitive Function in Elderly Women With Obesity
NCT ID: NCT05841173
Last Updated: 2023-05-06
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-01-09
2023-12-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
The participants are randomised for 5 arms. In the case of arms 1 and 2, they are prescribed to consume 2 doses of product per day without awareness of either it is the investigational product or a placebo (the investigational product or a placebo). Field investigators prescribe to participants product N1 or N2 according to group allocation without awareness of either it is the investigational product or a placebo.
Study Groups
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The Product Group
The Product group is prescribed with the investigated product - exogeneous ketone bodies.
"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.
The Combined Intervention Group
The Combined Intervention Group is prescribed with the investigated product -in combination with regular physical trainings.
"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.
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).
The Placebo Group
The Placebo Group is prescribed with the Placebo.
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.
The Diet Group
The Diet Group is prescribed with the Diet designed with 500 kcal reduction from daily energy expenditure.
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.
The Control Group
The Control Group is prescribed with standard recommendations for weight loss.
No interventions assigned to this group
Interventions
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"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.
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).
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 60 and over;
3. BMI 30.0 kg/m2 or more.
Exclusion Criteria
2. age under 60;
3. BMI \<30.0 kg/m2;
4. patients unable or unwilling to comply with the requirements of the protocol, including the signing of informed consent (inability to give such consent due to mental deficiency or language barrier), as well as non-compliance with the schedule of visits, persons unable to independently make a decision and sign an informed consent;
5. less than 6 months after suffering cardiovascular events, stroke, severe surgical interventions and injuries;
6. alcohol abuse (including chronic pancreatitis of alcoholic etiology) or drug addiction at present or within the last 5 years;
7. history of malignant diseases, regardless of the treatment during the last 5 years;
8. less than 4 weeks after suffering acute infectious and / or inflammatory diseases, after the onset of complete clinical and laboratory remission;
9. pregnancy and lactation;
10. history of allergic reactions to components of the study product and/or placebo or intolerance to components of the study product and/or placebo.
60 Years
75 Years
FEMALE
No
Sponsors
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Federal Stare Budgetary Scientific Institution, Mental Health Research Center
OTHER
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
OTHER
Responsible Party
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Principal Investigators
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Antonina V. Starodubova, MD, Full PhD
Role: STUDY_DIRECTOR
Deputy Director of the Federal Research Centre of Nutrition, Biotechnology and Food Safety
Yurgita R. Varaeva, MD, MRes
Role: PRINCIPAL_INVESTIGATOR
Research Fellow of the Federal research Centre of Nutrition, Biotechnology and Food Safety
Locations
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Nutrition Clinic of the Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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References
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Dadarlat-Pop A, Sitar-Taut A, Zdrenghea D, Caloian B, Tomoaia R, Pop D, Buzoianu A. Profile of Obesity and Comorbidities in Elderly Patients with Heart Failure. Clin Interv Aging. 2020 Apr 21;15:547-556. doi: 10.2147/CIA.S248158. eCollection 2020.
Abdoli N, Salari N, Darvishi N, Jafarpour S, Solaymani M, Mohammadi M, Shohaimi S. The global prevalence of major depressive disorder (MDD) among the elderly: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2022 Jan;132:1067-1073. doi: 10.1016/j.neubiorev.2021.10.041. Epub 2021 Nov 4.
Khovasova NO, Vorobyeva NM, Tkacheva ON, Kotovskaya YV, Naumov AV, Selezneva EV, Ovcharova LN. [The prevalence of anemia and its associations with other geriatric syndromes in subjects over 65 years old: data of Russian epidemiological study EVKALIPT]. Ter Arkh. 2022 Jan 15;94(1):24-31. doi: 10.26442/00403660.2022.01.201316. Russian.
Martinchik AN, Laikam KE, Kozyreva NA, Keshabyants EE, Mikhailov NA, Baturin AK, Smirnova EA. [The prevalence of obesity in various socio-demographic groups of the population of Russia]. Vopr Pitan. 2021;90(3):67-76. doi: 10.33029/0042-8833-2021-90-3-67-76. Epub 2021 May 17. Russian.
Hou Q, Guan Y, Yu W, Liu X, Wu L, Xiao M, Lu Y. Associations between obesity and cognitive impairment in the Chinese elderly: an observational study. Clin Interv Aging. 2019 Feb 15;14:367-373. doi: 10.2147/CIA.S192050. eCollection 2019.
Vidyanti AN, Hardhantyo M, Wiratama BS, Prodjohardjono A, Hu CJ. Obesity Is Less Frequently Associated with Cognitive Impairment in Elderly Individuals: A Cross-Sectional Study in Yogyakarta, Indonesia. Nutrients. 2020 Jan 30;12(2):367. doi: 10.3390/nu12020367.
Wang H, Hai S, Liu YX, Cao L, Liu Y, Liu P, Yang Y, Dong BR. Associations between Sarcopenic Obesity and Cognitive Impairment in Elderly Chinese Community-Dwelling Individuals. J Nutr Health Aging. 2019;23(1):14-20. doi: 10.1007/s12603-018-1088-3.
Colleluori G, Villareal DT. Aging, obesity, sarcopenia and the effect of diet and exercise intervention. Exp Gerontol. 2021 Nov;155:111561. doi: 10.1016/j.exger.2021.111561. Epub 2021 Sep 23.
Kokkinidis DG, Armstrong EJ, Giri J. Balancing Weight Loss and Sarcopenia in Elderly Patients With Peripheral Artery Disease. J Am Heart Assoc. 2019 Jul 2;8(13):e013200. doi: 10.1161/JAHA.119.013200. Epub 2019 Jun 29.
Giudici KV, Guyonnet S, Rolland Y, Vellas B, de Souto Barreto P, Nourhashemi F; MAPT/DSA Group. Body Weight Variation Patterns as Predictors of Cognitive Decline over a 5 Year Follow-Up among Community-Dwelling Elderly (MAPT Study). Nutrients. 2019 Jun 18;11(6):1371. doi: 10.3390/nu11061371.
Bosello O, Vanzo A. Obesity paradox and aging. Eat Weight Disord. 2021 Feb;26(1):27-35. doi: 10.1007/s40519-019-00815-4. Epub 2019 Dec 21.
Semlitsch T, Stigler FL, Jeitler K, Horvath K, Siebenhofer A. Management of overweight and obesity in primary care-A systematic overview of international evidence-based guidelines. Obes Rev. 2019 Sep;20(9):1218-1230. doi: 10.1111/obr.12889. Epub 2019 Jul 8.
Petroni ML, Caletti MT, Dalle Grave R, Bazzocchi A, Aparisi Gomez MP, Marchesini G. Prevention and Treatment of Sarcopenic Obesity in Women. Nutrients. 2019 Jun 8;11(6):1302. doi: 10.3390/nu11061302.
Falck RS, Davis JC, Best JR, Crockett RA, Liu-Ambrose T. Impact of exercise training on physical and cognitive function among older adults: a systematic review and meta-analysis. Neurobiol Aging. 2019 Jul;79:119-130. doi: 10.1016/j.neurobiolaging.2019.03.007. Epub 2019 Mar 26.
Ilyas Z, Perna S, A Alalwan T, Zahid MN, Spadaccini D, Gasparri C, Peroni G, Faragli A, Alogna A, La Porta E, Ali Redha A, Negro M, Cerullo G, D'Antona G, Rondanelli M. The Ketogenic Diet: Is It an Answer for Sarcopenic Obesity? Nutrients. 2022 Jan 30;14(3):620. doi: 10.3390/nu14030620.
Buckinx F, Aubertin-Leheudre M. Nutrition to Prevent or Treat Cognitive Impairment in Older Adults: A GRADE Recommendation. J Prev Alzheimers Dis. 2021;8(1):110-116. doi: 10.14283/jpad.2020.40.
McDonald TJW, Cervenka MC. Lessons learned from recent clinical trials of ketogenic diet therapies in adults. Curr Opin Clin Nutr Metab Care. 2019 Nov;22(6):418-424. doi: 10.1097/MCO.0000000000000596.
Other Identifiers
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ВОВ-01
Identifier Type: -
Identifier Source: org_study_id
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