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Effects of pumpkin (Cucurbita ficifolia Bouché) in lipid and glycemic profile of type 2 diabetics individuals: a randomized double blinded clinical trial

In vivo evaluation and monitoring with nanosensors effect hypoglycemic of cucurbita ficifolia Bouché in type 2 diabetic patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-7b5hhk
Enrollment
Unknown
Registered
2016-08-23
Start date
2012-11-05
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

Test of tolerance to abnormal glucose and insulin-dependent diabetes mellitus.

Interventions

The volunteers hyperglycemic (> 100 to < 300 mg/dL) were divided randomly into two groups and followed for 30 days: - Pumpkin Group (n = 16) participants received gel capsules 3 times a day of dry ext
Dietary supplement
B01.650.940.800.575.100.300.222

Sponsors

Embrapa Hortaliças
Lead Sponsor
Universidade de Brasília
Collaborator

Eligibility

Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals diagnosed with pre-diabetes (> 100 to 126 to < 300 mg/dL).

Exclusion criteria

Exclusion criteria: Individuals diagnosed with Type 2 diabetes for over 6 months with blood glucose > 300 mg/dL.

Design outcomes

Primary

MeasureTime frame
Dietary assessment (energy, macronutrients and fiber), anthropometric (weight, height, BMI and WC)and metabolic profile (plasma glucose, insulin, glycated hemoglobin, HOMA-IR, HOMA-B, peptíceo-C, total cholesterol (TC), triglycerides (TGL), HDL-C, LDL-C, Total lipid, TC/HDL and PA).;Dietary assessmen: participants were asked to complete a 3-day dietary record in nonconsecutive days, one for the weekend and two for week days. A trained researcher provided subjects with detailed instructions on how to fill the dietary records. A researcher reviewed all diet records upon return for accuracy. All participants were instructed to maintain their usual dietary intake and level of physical activity and not to consume other hypoglycemic plants throughout the study. All dietary records were analyzed to provide an estimation of daily average energy and nutrient intake by using the software Dietpro5i (Viçosa, Brazil). Anthropometric assessment: data on anthropometric indices including body weight, height, waist circumference (WC) and BMI were obtained at the beginning and end of the trial. Body weight was measured in a fasting state, without shoes and wearing light clothing to the nearest 0.5 kg accuracy using a weighing calibrated scale (Seca, Hamburg, Germany). Height was measured by mounted tape, without shoes and at a standing position near to the wall to the nearest 0.1 cm accuracy using a stadiometer (Seca, Hamburg, Germany). WC was measured by nonstretching tape measure around the abdomen. BMI was calculated by dividing weight in kilogram by height in meters squared. Blood sampling and biochemical measurements: fasting blood samples (10 mL) from each participant were taken in the in the early morning after an overnight fast. Blood samples, collected into tubes containing 0.1% EDTA, were taken in a sitting position according to a standard protocol and centrifuged at 3000 rpm for 15 min of collection. The samples were centrifuged to separate the plasma, which were then s

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactLidiane Muniz

Universidade de Brasília

lidianebmuniz@gmail.com+55(61)982849657

Outcome results

None listed

Source: REBEC (via WHO ICTRP)