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

NCT05841173 | Unknown

• 1 other identifier: ВОВ-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderly; Obesity; Weight loss; Cognitive Change; Exogenous Ketones; Diet; Physical activity

Outcome Measures

Primary Outcomes (7)

• Change from baseline body weight at 12 weeks

  The dynamics of body weight

  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

  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)).

  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).

  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

  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

  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

  Baseline (visit 1) and after 12 weeks (visit 2)

Secondary Outcomes (14)

• Change from baseline fat mass at 12 weeks

  Baseline (visit 1) and after 12 weeks (visit 2)

• Change from baseline skeletal muscle mass at 12 weeks

  Baseline (visit 1) and after 12 weeks (visit 2)

• Change from baseline visceral fat at 12 weeks

  Baseline (visit 1) and after 12 weeks (visit 2)

• Change from baseline total cholesterol serum levels at 12 weeks

  Baseline (visit 1) and after 12 weeks (visit 2)

• Change from baseline LDL-cholesterol serum levels at 12 weeks

  Baseline (visit 1) and after 12 weeks (visit 2)

Study Arms (5)

The Product Group

EXPERIMENTAL

The Product group is prescribed with the investigated product - exogeneous ketone bodies.

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.

Dietary Supplement: "PanTrek"; Behavioral: Physical Trainings

The Placebo Group

PLACEBO COMPARATOR

The Placebo Group is prescribed with the Placebo.

Other: Placebo

The Diet Group

ACTIVE COMPARATOR

The Diet Group is prescribed with the Diet designed with 500 kcal reduction from daily energy expenditure.

Behavioral: Diet

The Control Group

NO INTERVENTION

The Control Group is prescribed with standard recommendations for weight loss.

Interventions

"PanTrek" DIETARY_SUPPLEMENT

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.

Also known as: Exogenous ketone bodies

The Combined Intervention Group; The Product Group

Physical Trainings BEHAVIORAL

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).

Also known as: Exercises

The Combined Intervention Group

Placebo OTHER

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 Placebo Group

Diet BEHAVIORAL

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 Diet Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Gender Eligibility Details: The females participants are reqruited In order to reduce variability of results in the restricted sample size (40 person per group).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female;
• Age 60 and over;
• BMI 30.0 kg/m2 or more.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• Federal Stare Budgetary Scientific Institution, Mental Health Research Center: collaborator

Study Sites (1)

Nutrition Clinic of the Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, 115446, Russia

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonina V. Starodubova, MD, Full PhD

  Deputy Director of the Federal Research Centre of Nutrition, Biotechnology and Food Safety

  STUDY DIRECTOR

• Yurgita R. Varaeva, MD, MRes

  Research Fellow of the Federal research Centre of Nutrition, Biotechnology and Food Safety

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurgita R. Varaeva, MD, MRes

CONTACT

+79253841894; YurgitaVaraeva@gmail.com

Antonina V. Starodubova, MD, Full PhD

CONTACT

+79167470606; avs.ion@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking is used between 2 groups out of 5 (between the Product group and Placebo group). The investigated product and Placebo have comparable organoleptic properties and are packed in the same containers labelled as N1 or N2. 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomised parallel arms double control interventional study

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 3, 2023
• Study Start: January 9, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)