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New low-salt foods seasoned with grape extracts: sensory evaluation and functional assessment in the prevention of hypertension and control of glycaemia

Hypertension- and glycaemia-lowering effects of a grape-pomace-derived seasoning in patients and healthy volunteers. Interplay with the gut microbiome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13100451
Enrollment
30
Registered
2020-11-27
Start date
2017-06-01
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Management of metabolic risk factors of metabolic syndrome Nutritional, Metabolic, Endocrine

Interventions

First, volunteers will receive information about the study, a survey of dietary habits and several recipes low in sodium salt. In addition, they will have to sign a printed consent to participate in t

Sponsors

Institute of Food Science Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 05/11/2021: Patients: Presenting with at least two of the following risk factors of metabolic syndrome: 1. Hypertension (systolic BP =130 mmHg or diastolic BP >85 mmHg) 2. Hypercholesterolemia (HDL colesterol 150 mg/dl) 4. Increased fasting plasma glucose (>100 mg/dl) 5. Increased waist circumference (>94 cm in men and >80 cm in women) Healthy participants: Presenting with normal values of the parameters mentioned above. Previous participant inclusion criteria: Participants have to present at least two of the following risk factors of metabolic syndrome: 1. Hypertension (systolic BP =130 mmHg or diastolic BP >85 mmHg) 2. Hypercholesterolemia (HDL colesterol 150 mg/dl) 4. Increased fasting plasma glucose (>100 mg/dl) 5. Increased waist circumference (>94 cm in men and >80 cm in women)

Exclusion criteria

Exclusion criteria: 1. Serious cardiovascular disease 2. Antibiotic intake up to 3 months before the study 3. Endocrine and gastrointestinal disorders 4. Addiction to drugs or alcohol 5. Restrictive diets (vegetarians, vegans)

Design outcomes

Primary

MeasureTime frame
1. Full serum count, erythrocyte sedimentation rate, c-reactive protein, sodium, potassium, chloride, bicarbonate, urea, creatinine, bilirubin, gamma-glutamyl transferase, total protein, albumin, calcium, phosphate, uric acid, random blood glucose, cholesterol, high-density lipoprotein, low-density lipoprotein and triglycerides; measured using a blood test at baseline and at the end of the control/intervention period 2. Blood pressure (mmHg), height (cm), weight (kg), waist diameter (cm) and hip circumference (cm) measured at baseline and at the end of the control/intervention period

Secondary

MeasureTime frame
1. Short-chain fatty acids (SCFA) and phenolic metabolites analysed in faecal samples by gas chromatography–mass spectrometry (GC-MS) and ultra-high performance liquid chromatography mass spectrometry (UHPLC–MS), respectively, according to previous laboratory procedures at baseline and at the end of the control/intervention period 2. Microbiota sequencing analysis of faecal samples following a bacteria metagenomic approach (Illumina technology) at baseline and at the end of the control/intervention period

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026