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Chlorella supplementation produces anti-inflammatory activity and improves quality of life in pre-diabetic and diabetic patients

Modulating activity of the alga Chlorella in glucose intolerant and type-2 diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8rvrb5
Enrollment
Unknown
Registered
2020-09-24
Start date
2015-03-01
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

pré-diabetes and type-2 diabetes patients

Interventions

30 patients with type-2 diabetes, 25 patients with pre-diabetes, and 25 healthy volunteers will be recruited and, if they fullfill eligibility criteria and agree to participate, they will be submmited
Dietary supplement
B01.650.940.150.469.400

Sponsors

Hemocentro Universidade Estadual de Campinas
Lead Sponsor
Hemocentro Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Healthy, pre-diabetic or diabetic volunteers, attended at CECOM of UNICAMP; both genders; age between 18 and 75 years; continue with their therapeutic treatment; signed informed consent form.

Exclusion criteria

Exclusion criteria: History of drug or alcohol abuse; diagnosis of type 1 diabetes; decompensated blood pressure; diagnoses of severe psychiatric, renal, cardiac, pulmonary, autoimmune diseases, cancer and immunodeficiencies; pregnancy and lactation; hypersensitivity to iodine; use of immunosuppressants and warfarin.

Design outcomes

Primary

MeasureTime frame
Improvement of metabolic complication: variation of at least 5% in the pre- and post-intervention measurements of blood glucose levels; Improvement of inflammatory complications: variation of at least 5% in the pre and post-intervention measurements of TNF alpha levels; Improvement of quality of life: variation of at least 5% in the pre and post-intervention measurements, measured through the Short-Form Health Survey (SF-36) questionnaire composed of 36 questions, covering 8 domains (functional capacity , physical aspects, presence or absence of disabling pain, general health, vitality, social aspects, emotional aspects and mental health).—

Secondary

MeasureTime frame
At least 5% variation in pre- and post-intervention measurements of leptin, adiponectin, resistin, glucagon, glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP), and cytokine levels: interleukin (IL)-6, IL-1, MCP-1, MIF, RANTES and IL-10; At least 5% variation in pre- and post-intervention measurements of the intestinal microbiota and miRNAs 375 and 126.—

Countries

Brazil

Contacts

Public ContactMary Luci Queiroz

Hemocentro Universidade Estadual de Campinas

mlsq@fcm.unicamp.br+55-019-35218752

Outcome results

None listed

Source: REBEC (via WHO ICTRP)