ObesityNCT05841173
Effects of Weight Loss Management on Cognitive Function in Elderly Women With Obesity
A study testing "PanTrek", Physical Trainings and Diet in people with Obesity and Cognitive Change, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Obesity, Cognitive Change
- What is being tested?
- "PanTrek", Physical Trainings and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female;
- Age 60 and over;
- BMI 30.0 kg/m2 or more.
Who cannot join
- Male;
- age under 60;
- BMI <30.0 kg/m2;
- 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;
- less than 6 months after suffering cardiovascular events, stroke, severe surgical interventions and injuries;
- alcohol abuse (including chronic pancreatitis of alcoholic etiology) or drug addiction at present or within the last 5 years;
Show all 10Show fewer
- history of malignant diseases, regardless of the treatment during the last 5 years;
- less than 4 weeks after suffering acute infectious and / or inflammatory diseases, after the onset of complete clinical and laboratory remission;
- pregnancy and lactation;
- history of allergic reactions to components of the study product and/or placebo or intolerance to components of the study product and/or placebo.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Nutrition Clinic of the Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, 115446
Antonina V. Starodubova, MD, Full PhD, 0079167470606, avs.ion@yandex.ru
Yurgita R. Varaeva, MD, MRes, 0079253841894, YurgitaVaraeva@gmail.com
About this study
Official title: Effects of Weight Loss Management on Cognitive Function in Elderly Obese Women
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.
Read the 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
- Being tested
- "PanTrek", Physical Trainings, Placebo, Diet
- Keywords
- Elderly, Obesity, Weight loss, Cognitive Change, Exogenous Ketones, Diet, Physical activity
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"PanTrek"Dietary supplement
Also called Exogenous ketone bodies
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 TrainingsBehavioural
Also called Exercises
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).
PlaceboOther
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.
DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Product Group | Experimental | The Product group is prescribed with the investigated product - exogeneous ketone bodies. Receives: Dietary Supplement: "PanTrek" |
| The Combined Intervention Group | Active comparator | The Combined Intervention Group is prescribed with the investigated product -in combination with regular physical trainings. Receives: Dietary Supplement: "PanTrek"; Behavioral: Physical Trainings |
| The Placebo Group | Placebo comparator | The Placebo Group is prescribed with the Placebo. Receives: Other: Placebo |
| The Diet Group | Active comparator | The Diet Group is prescribed with the Diet designed with 500 kcal reduction from daily energy expenditure. Receives: Behavioral: Diet |
| The Control Group | No intervention | The Control Group is prescribed with standard recommendations for weight loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body weight at 12 weeks
The dynamics of body weight
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Montreal Cognitive Assessment (MoCa) test scores at 12 weeks
The changes in the cognitive testing results
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Trail Making Test (TMT) a&b test scores at 12 weeks
The changes in the cognitive testing results (normal range - less than 78 and 273 seconds (=scores)).
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Word recall test scores at 12 weeks
The changes in the cognitive testing results (normal range as 45 words (=scores) and more out of 5 repetitions). Minimal - 0 (worse result), maximal score - 50 (excellent result).
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Mean response time in the test "Schulte tables" at 12 weeks
The changes in the cognitive testing results
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline The Stroop Color and Word Test results at 12 weeks
The changes in the cognitive testing results
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Verbal fluency test results at 12 weeks
The changes in the cognitive testing results
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Secondary outcomes (14)
Change from baseline fat mass at 12 weeks
The changes in the fat mass according to the bioimpedance analysis
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline skeletal muscle mass at 12 weeks
The changes in the skeletal muscle mass according to the bioimpedance analysis
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline visceral fat at 12 weeks
The changes in visceral fat according to the bioimpedance analysis
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline total cholesterol serum levels at 12 weeks
The changes of total cholesterol serum levels
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline LDL-cholesterol serum levels at 12 weeks
The changes of LDL-cholesterol serum levels
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline HOMA-IR (homeostasis model assessment - insulin resistance) index at 12 weeks
The changes of HOMA-IR index
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline C-reactive protein (CRP) serum levels at 12 weeks
The changes of CRP serum levels
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Tumor Necrosis Factor Alpha (TNFa) serum levels at 12 weeks
The changes of TNFa serum levels
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline systolic blood pressure (SBP) at 12 weeks
The changes of SBP
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline diastolic blood pressure (DBP) at 12 weeks
The changes of DBP
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline grip strength at 12 weeks
The changes of grip strength measured by grip dynamometer on the leading hand
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Six Minute Walk Test distance at 12 weeks
The changes of Six Minute Walk Test results
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Hamilton Anxiety Rating Scale at 12 weeks
The changes of Hamilton Anxiety Rating Scale results (normal range - 6 scores and less).
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Hamilton Depression Rating Scale at 12 weeks
The changes of Hamilton Depression Rating Scale results (normal range - 7 scores and less).
Measured: Baseline (visit 1) and after 12 weeks (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start9 Jan 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised parallel arms double control interventional study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- Federal Stare Budgetary Scientific Institution, Mental Health Research Center
- Responsible party
- Sponsor
- Investigators
- Antonina V. Starodubova, MD, Full PhD, Study director, Deputy Director of the Federal Research Centre of Nutrition, Biotechnology and Food SafetyYurgita R. Varaeva, MD, MRes, Principal investigator, Research Fellow of the Federal research Centre of Nutrition, Biotechnology and Food Safety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841173
- Sponsor's protocol ID
- ВОВ-01
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32368021Abdoli 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.
PubMed 34742925Khovasova 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.
PubMed 36286917Martinchik 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.
PubMed 34264558Hou 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.
PubMed 30863030Vidyanti 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.
PubMed 32019161Wang 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.
PubMed 30569063Colleluori 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.
PubMed 34562568Kokkinidis 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.
PubMed 31257976Giudici 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.
PubMed 31216732Bosello 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.
PubMed 31865598Semlitsch 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.
PubMed 31286668Petroni 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.
PubMed 31181771Falck 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.
PubMed 31051329Ilyas 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.
PubMed 35276979
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Loss Management on Cognitive Function in Elderly Obese Women
- ClinicalTrials.gov ID
- NCT05841173
- Acronym / sponsor ID
- ВОВ-01
- Conditions
- Obesity, Cognitive Change
- Keywords
- Elderly, Obesity, Weight loss, Cognitive Change, Exogenous Ketones, Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- Federal Stare Budgetary Scientific Institution, Mental Health Research Center
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Prospective randomised parallel arms double control interventional study
| Arm | Type | Receives |
|---|---|---|
| The Product Group | Experimental | Dietary Supplement: "PanTrek"The Product group is prescribed with the investigated product - exogeneous ketone bodies. |
| The Combined Intervention Group | Active comparator | Dietary Supplement: "PanTrek", Behavioral: Physical TrainingsThe Combined Intervention Group is prescribed with the investigated product -in combination with regular physical trainings. |
| The Placebo Group | Placebo comparator | Other: PlaceboThe Placebo Group is prescribed with the Placebo. |
| The Diet Group | Active comparator | Behavioral: DietThe Diet Group is prescribed with the Diet designed with 500 kcal reduction from daily energy expenditure. |
| The Control Group | No intervention | –The Control Group is prescribed with standard recommendations for weight loss. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female;
- Age 60 and over;
- BMI 30.0 kg/m2 or more.
Key exclusion criteria (10 listed)
- Male;
- age under 60;
- BMI <30.0 kg/m2;
- 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;
- less than 6 months after suffering cardiovascular events, stroke, severe surgical interventions and injuries;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "PanTrek"Also: Exogenous ketone bodiesThe 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. | Dietary supplement | The Combined Intervention Group, The Product Group |
| Physical TrainingsAlso: ExercisesPhysical 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). | Behavioural | The Combined Intervention Group |
| PlaceboThe 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. | Other | The Placebo Group |
| DietThe 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. | Behavioural | The Diet Group |
Primary outcome
Change from baseline body weight at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The dynamics of body weight
Change from baseline Montreal Cognitive Assessment (MoCa) test scores at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results
Change from baseline Trail Making Test (TMT) a&b test scores at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results (normal range - less than 78 and 273 seconds (=scores)).
Change from baseline Word recall test scores at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results (normal range as 45 words (=scores) and more out of 5 repetitions). Minimal - 0 (worse result), maximal score - 50 (excellent result).
Change from baseline Mean response time in the test "Schulte tables" at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results
Change from baseline The Stroop Color and Word Test results at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results
Change from baseline Verbal fluency test results at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
The changes in the cognitive testing results
14 secondary outcomes
Change from baseline fat mass at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline skeletal muscle mass at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline visceral fat at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline total cholesterol serum levels at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline LDL-cholesterol serum levels at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline HOMA-IR (homeostasis model assessment - insulin resistance) index at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline C-reactive protein (CRP) serum levels at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Tumor Necrosis Factor Alpha (TNFa) serum levels at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline systolic blood pressure (SBP) at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline diastolic blood pressure (DBP) at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline grip strength at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Six Minute Walk Test distance at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Hamilton Anxiety Rating Scale at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Change from baseline Hamilton Depression Rating Scale at 12 weeks
Time frame: Baseline (visit 1) and after 12 weeks (visit 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 32368021Dadarlat-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.
- Background: PubMed 34742925Abdoli 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.
- Background: PubMed 36286917Khovasova 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.
- Background: PubMed 34264558Martinchik 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.
- Background: PubMed 30863030Hou 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.
- Background: PubMed 32019161Vidyanti 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.
- Background: PubMed 30569063Wang 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.
- Background: PubMed 34562568Colleluori 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.
- Background: PubMed 31257976Kokkinidis 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.
- Background: PubMed 31216732Giudici 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.
- Background: PubMed 31865598Bosello 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.
- Background: PubMed 31286668Semlitsch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonina V. Starodubova, MD, Full PhD study director
Deputy Director of the Federal Research Centre of Nutrition, Biotechnology and Food Safety
Yurgita R. Varaeva, MD, MRes principal investigator
Research Fellow of the Federal research Centre of Nutrition, Biotechnology and Food Safety
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "PanTrek", Physical Trainings and Diet in people with Obesity and Cognitive Change, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yurgita R. Varaeva, MD, MRes (+79253841894, YurgitaVaraeva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body weight at 12 weeks (time frame: Baseline (visit 1) and after 12 weeks (visit 2)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841173, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.