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Physical Exercise associated with daily whey protein supplementation in the management of Type 2 Diabetes Mellitus in older adults

Combined Training associated with Daily whey Protein Supplementation in the treatment of Type 2 Diabetes Mellitus in older adults: randomized triple-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4fsvs6y
Enrollment
Unknown
Registered
2025-07-01
Start date
2024-05-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight by Height

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. The population of the present study will consist of older adults of both sexes living with type 2 diabetes (T2DM), aged between 6

Sponsors

Universidade São Judas Tadeu
Lead Sponsor
Instituto de Ortopedia e Traumatologia do Hospital das Clínica da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Male
Age
65 Years to 79 Years

Inclusion criteria

Inclusion criteria: Elderly participants with type 2 diabetes mellitus; aged between 65 and 79 years; male; on a stable dose of medication (oral antidiabetics, insulin, or a combination of both) for three or more months; glycated hemoglobin between 6% and 10.0%; without renal function impairment, which will be assessed using the Modification of Diet in Renal Disease (MDRD) formula, including only those with values above 60 ml/min; without musculoskeletal system impairment, pain, or any disabling disease or previous surgeries that prevent exercise; without inadequately treated or decompensated chronic non-communicable diseases, especially systemic arterial hypertension; with cognitive function within the normal range; assessed by the MoCA; considering cutoff scores according to the participant's educational level

Exclusion criteria

Exclusion criteria: Inability to undergo assessments and reassessments; having more than three absences during the training period; experiencing any adverse events related to musculoskeletal pain or worsening of symptoms or signs of pre-existing diseases; particularly changes in systemic blood pressure

Design outcomes

Primary

MeasureTime frame
A reduction in glycated hemoglobin (HbA1c) levels is expected, with a decrease of at least 0.5% after 12 weeks of intervention. The variable will be assessed through laboratory testing, performed one week before the start and one week after the end of the intervention. The objective is to compare the groups to evaluate the effects of the poliprotective strategy (dietary counseling, whey protein supplementation, and combined exercise) on the metabolic control of older adults with type 2 diabetes mellitus.

Secondary

MeasureTime frame
An improvement in physical performance is expected after 12 weeks of intervention, assessed through a battery of functional tests. These include handgrip strength (in kg/f), the Short Physical Performance Battery (SPPB) — total score ranging from 0 to 12, comprising balance, gait speed, and chair stand tests (in seconds), the Timed Up and Go (TUG) test with and without a cognitive task (in seconds), and the Senior Fitness Tests: upper and lower limb flexibility (in centimeters), upper and lower limb strength (number of repetitions), mobility (in seconds), and the 6-minute walk test (in meters). Data will be collected one week before the intervention and one week after its completion.

Countries

Brazil

Contacts

Public ContactJoselma dos Santos

Universidade São Judas Tadeu

joselma.rodrigues@hotmail.com+55(11)962309359

Outcome results

None listed

Source: REBEC (via WHO ICTRP)