Effect of supplementation of nondigestible fibers and bacteria of beneficial effect to the body on blood tests, symptoms of depression and diabetes in patients with type 1 and 2 diabetes.

Effect of prebiotic and simbiotic supplementation on lipidic and glycemic profile, inflammatory markers and symptoms of depression and anxiety in individuals with diabetes mellitus type 1 and 2: randomized clinical trial, placebo-controlled and triple blind

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-63czrx

Enrollment

Unknown

Registered

2018-01-19

Start date

2017-11-15

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

Diabetes mellitus, Type 1 diabetes, type 2 diabetes, depression, anxiety, inflamation

Interventions

Intervention: prebiotic - 50 participants, consumption of 2 sachets / day of 6g each, totaling 12g / day, diluted in 100mL of water at room temperature for 30 days Intervention: symbiotic - 50 partic

Dietary supplement

D09.698.718.622

G07.203.300.456.716

Eligibility

Age

19 Years to 90 Years

Inclusion criteria

Inclusion criteria: Volunteers who are diagnosed with type 1 or type 2 diabetes mellitus; both genders; age above 19 years.

Exclusion criteria

Exclusion criteria: Individuals with previous gastrointestinal diseases; previous gastrointestinal surgeries; intolerances or food allergies; use of anti-inflammatory drugs or antibiotics up to three months prior to study or during study; regular use of laxatives; use of opioid narcotic analgesics; use of appetite suppressants; current or previous use up to one month of probiotic symbiotic prebiotics or products enriched with these ingredients; presenting intolerance to prebiotics or probiotics or symbiotics; pregnant or lactating women; following a diet for weight loss or gain in the last three months; current follow-up of unusual diets; alcohol dependence; illicit drugs and smokers.

Design outcomes

Primary

Measure	Time frame
Fasting glycemia will be determined by the enzymatic method, according to the manufacturer's instructions at baseline and beginning of the supplementation, 30 days after the beginning of the supplementation that will also be the day of completion and 30 days after completion of supplementation. The concentrations will be expressed in mg / dL and will be considered as normal values ??less than or equal to 99 mg / dL, pre diabetes between 100 and 125 mg / dL and diabetes mellitus values ??equal to or greater than 126 mg / dL. Fasting Insulin: will be determined by the chemiluminescent immunoassay Siemens Healthcare Diagnostics Inc., Newark, DE, USA. at baseline and beginning of supplementation, 30 days after the start of the supplementation, which will also be the end day and 30 days after the end of the supplementation. The concentrations will be expressed in IU / mL, the desirable value being up to 29.1 ?IU / mL. Total cholesterol and high density lipoprotein and serum triglycerides will be determined by the enzymatic colorimetric method according to the manufacturer's instructions Dimension RxL Max - Siemens Healthcare Diagnostics Inc. Newark, DE, USA. at baseline and beginning of supplementation, 30 days after the start of the supplementation, which will also be the end day and 30 days after the end of the supplementation. Low-density lipoprotein will be determined using the Friedewald equation (LDL-c = Total cholesterol - HDL-c - Triglycerides / 5). Concentrations will be expressed in mg / dL for all variables and the desirable cholesterol value <200mg mg / dL, borderline between 200 and 239 mg / dL, and high values ??? 240 mg / dL will be considered for individuals over 20 years of age . HDL-c will be considered low when lower than 40 mg / dL, with values ??above 60 mg / dL being desirable regardless of gender. LDL-c <100 mg / dL will be considered optimal, desirable between 100 and 129 mg / dL, borderline between 130 and 159 mg / dL, high between 160 and 189 mg	—

Measure

Time frame

Fasting glycemia will be determined by the enzymatic method, according to the manufacturer's instructions at baseline and beginning of the supplementation, 30 days after the beginning of the supplementation that will also be the day of completion and 30 days after completion of supplementation. The concentrations will be expressed in mg / dL and will be considered as normal values ??less than or equal to 99 mg / dL, pre diabetes between 100 and 125 mg / dL and diabetes mellitus values ??equal to or greater than 126 mg / dL. Fasting Insulin: will be determined by the chemiluminescent immunoassay Siemens Healthcare Diagnostics Inc., Newark, DE, USA. at baseline and beginning of supplementation, 30 days after the start of the supplementation, which will also be the end day and 30 days after the end of the supplementation. The concentrations will be expressed in IU / mL, the desirable value being up to 29.1 ?IU / mL. Total cholesterol and high density lipoprotein and serum triglycerides will be determined by the enzymatic colorimetric method according to the manufacturer's instructions Dimension RxL Max - Siemens Healthcare Diagnostics Inc. Newark, DE, USA. at baseline and beginning of supplementation, 30 days after the start of the supplementation, which will also be the end day and 30 days after the end of the supplementation. Low-density lipoprotein will be determined using the Friedewald equation (LDL-c = Total cholesterol - HDL-c - Triglycerides / 5). Concentrations will be expressed in mg / dL for all variables and the desirable cholesterol value <200mg mg / dL, borderline between 200 and 239 mg / dL, and high values ??? 240 mg / dL will be considered for individuals over 20 years of age . HDL-c will be considered low when lower than 40 mg / dL, with values ??above 60 mg / dL being desirable regardless of gender. LDL-c <100 mg / dL will be considered optimal, desirable between 100 and 129 mg / dL, borderline between 130 and 159 mg / dL, high between 160 and 189 mg

—

Secondary

Measure	Time frame
C-reactive protein will be determined by the nephelometry method, according to the protocol described by BN II supplier, Siemens Healthcare Diagnostics Inc., Newark, DE, USA at baseline and beginning of supplementation, 30 days after initiation of supplementation that will also be the day of the end and 30 days after the end of the supplementation. Concentrations shall be expressed in mg / L. Interleukin-1, Interleukin-6, Interleukin-10 and Tumor Necrosis Factor, the Enzyme Linked Immunosorbent Assay (ELISA) will be used using specific kits according to the protocol described by the supplier BD OptEIATM, BD Biosciences, San Jose, California, USA at baseline and beginning of supplementation, 30 days after initiation of supplementation which will also be the day of completion and 30 days after completion of supplementation. Concentrations will be expressed in pg / mL. The Beck Depression Inventory (BDI), a scale consisting of 21 items, including symptoms and attitudes, whose intensity ranges from 0 to 3. The items refer to sadness, pessimism, sensation of failure, lack of satisfaction, guilt, punishment, self-deprecation, self-accusations, suicidal ideation, crying, irritability, social withdrawal, indecision, distortion of body image, inhibition of work, sleep disturbance, fatigue , loss of appetite, weight loss, somatic concern, decreased libido. The mood score will be calculated as the sum of the symptom scores mentioned above. Scores below 15, 15-19, 20-29 and 30-63 will be considered as normal, mild, moderate and severe depression, respectively, at baseline and beginning of supplementation, 30 days after the start of supplementation, which will also be the day of the end and 30 days after the end of the supplementation. For the evaluation of anxiety symptoms, the Trait-State Anxiety Inventory (IDATE) will be used, which presents two scales that evaluate anxiety as a state (IDATE-E) or trait. According to this inventory, the state scale requires the participant to	—

Measure

Time frame

C-reactive protein will be determined by the nephelometry method, according to the protocol described by BN II supplier, Siemens Healthcare Diagnostics Inc., Newark, DE, USA at baseline and beginning of supplementation, 30 days after initiation of supplementation that will also be the day of the end and 30 days after the end of the supplementation. Concentrations shall be expressed in mg / L. Interleukin-1, Interleukin-6, Interleukin-10 and Tumor Necrosis Factor, the Enzyme Linked Immunosorbent Assay (ELISA) will be used using specific kits according to the protocol described by the supplier BD OptEIATM, BD Biosciences, San Jose, California, USA at baseline and beginning of supplementation, 30 days after initiation of supplementation which will also be the day of completion and 30 days after completion of supplementation. Concentrations will be expressed in pg / mL. The Beck Depression Inventory (BDI), a scale consisting of 21 items, including symptoms and attitudes, whose intensity ranges from 0 to 3. The items refer to sadness, pessimism, sensation of failure, lack of satisfaction, guilt, punishment, self-deprecation, self-accusations, suicidal ideation, crying, irritability, social withdrawal, indecision, distortion of body image, inhibition of work, sleep disturbance, fatigue , loss of appetite, weight loss, somatic concern, decreased libido. The mood score will be calculated as the sum of the symptom scores mentioned above. Scores below 15, 15-19, 20-29 and 30-63 will be considered as normal, mild, moderate and severe depression, respectively, at baseline and beginning of supplementation, 30 days after the start of supplementation, which will also be the day of the end and 30 days after the end of the supplementation. For the evaluation of anxiety symptoms, the Trait-State Anxiety Inventory (IDATE) will be used, which presents two scales that evaluate anxiety as a state (IDATE-E) or trait. According to this inventory, the state scale requires the participant to

—

Countries

Brazil

Contacts

Public ContactErasmo Santos de Moraes Trindade

Universidade Federal de Santa Catarina

erasmotrindade@gmail.com+55 (48) 37219784

Outcome results

None listed

Source: REBEC (via WHO ICTRP)