2.4 g phytin to be consumed daily for a period of 2 weeks. Participants will consume 2 test capsules containing phytin, 3 times a day with a meal for a period of 2 weeks.

2.4 g MCC to be consumed daily for a period of 2 weeks. Participants will consume 2 placebo capsules, each containing microcrystalline cellulose, 3 times a day with a meal for a period of 2 weeks.

Diet Modification

Consumption of a rice extract, called phytin for a period of 2 weeks

Phytin, rice extract

Consumption of MCC, a placebo, for a period of 2 week

MCC, placebo

Quadram Institute Bioscience

QI NNUHFT Clinical Research Facility

Effect of Phytin on Human Gut Microbiome (EPoM)

A Human Intervention Trial Investigating the Effects of Phytin on the Human Gut Microbiome

To investigate whether consuming phytin for two weeks will cause a proportional decrease in human gut Enterobacteriaceae compared to the number of Enterobacteriaceae present in the participants' gut microbiome after consuming the control capsule.

To investigate whether the delivery of phytin to the colon for a period of two weeks will be associated with an increase in human gut bifidobacteriaceae through the chelation of iron, compared to the number of bifidobacteriaceae present in the participants' baseline gut microbiota, as determined by faecal bacteria phylogenic analysis

To ascertain whether consuming phytin modulates the gut microbial community as a whole, as compared to the consumption of a placebo capsule

To determine whether the consumption of phytin causes a change in short chain fatty acid levels in the faeces, via changes in the gut microbiome function

To determine whether the consumption of phytin causes a change in the available iron present in the faeces

To ascertain the extent of phytin degradation that takes place in the colon based on the known concentration of phytin administered via the capsule

To determine levels of calprotectin as a marker of gut inflammation

To determine levels of C-Reactive Protein (CRP) as a marker of systemic inflammation

To measure serum ferritin levels as a marker of the time of capsule release

Norfolk and Norwich University Hospitals NHS Foundation Trust

This process will be carried out by a QIB scientist who is not part of the study team.
Wendy Hollands (QIB Food Innovation and Health [FIH] scientist) will be responsible for this process, and therefore ensures the trial remains blinded to the study participants, Chief Investigators and study scientists/advisors.

Personalized diet added with quinoa and flaxseed

Personalized diet without dietary supplement

Metabolic Syndrome

Nutritional and Metabolic Diseases

Quinoa

Flaxseed

personalized diet added with quinoa and flaxseed

Quinoa and Flaxseed

Epidemiología y determinantes sociales asociados a la obesidad y la diabetes tipo 2 en México

NORMA Oficial Mexicana NOM-037-SSA2-2012, Para la prevención, tratamiento y control de las dislipidemias.

Diferencias entre la prevalencia de obesidad y exceso de peso estimadas con datos declarados o por medición directa en adultos de la Comunidad Valenciana

Consumer Acceptability of Muffins with Flaxseed (Linum usitatissimum)

Flavonoids and other phenolic compounds in Andean indigenous grains: Quinoa (Chenopodium quinoa), kañiwa (Chenopodium pallidicaule) and kiwicha (Amaranthus caudatus)

Nutraceuticals and Functional Foods in Health Promotion and Disease Risk Reduction

Inhibition of reverse transcriptases by flavonoids

Utilidad de la Prueba de Micronúcleos y Anormalidades Nucleares en Células Exfoliadas de Mucosa Oral en la Evaluación de Daño Genotóxico y Citotóxico

Procedimientos básicos de la prueba de micronúcleos y anormalidades nucleares en células exfoliadas de mucosa oral

Una nueva definición mundial del síndrome metabólico propuesta por la Federación Internacional de Diabetes: fundamento y resultados

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Efect of Quinoa and Flaxseed in Cititoxicity and Glicemic Control in Metabolic Syndrome Patients

Evaluation of the Citotoxicity and Clicemic Control of Subject With Metabolic Syndrome Managed With Conventional Nutritional Tratment More Quinoa, Flaxseed or Borh Versus Conventional Nutrition

The number of micronuclei will be evaluated at baseline at 12 weeks and 24 weeks with Schmidt technique by Giemsa/wright and the entered values reflect the number of micronuclei at week 24

The fasting glucose levels will be evaluated at baseline, at 12 weeks and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at 24 weeks

Glycosylated hemoglobin will be evaluated at baseline, at 12 weeks and 24 weeks by high-pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at 24 weeks

The body weight will be measured at baseline, at 12 weeks and 24 weeks with a bioimpedance balance and the entered values reflect the body weight at 24 weeks

Body Mass Index will be calculated at baseline, 12 weeks and 24 weeks with the Quetelet index formula and the entered values reflect the body mass index at 24 weeks

Waist circumference will be evaluated at baseline and at 24 weeks with a flexible tape

Total cholesterol levels will be evaluated at baseline and 24 weeks by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at 24 weeks

Triglycerides levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at 24 weeks

c-HDL levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at 24 weeks

c-LDL levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at 24 weeks

Blood pressure will be measured at baseline and 24 weeks with a digital sphygmomanometer and the entered values reflect the blood pressure at 24 weeks

El uso de los datos es exclusivo de los investigadores involucrados en el estudio sin la devulgacion de los mismos a terceros externos al equipo de trabajo

Ana Lilia Fletes Rayas

PROFESSOR ASSOCIATE TYPE A

University of Guadalajara

Hospital Civil de Guadalajara

An open clinical trial with randomization plus control group

Patients who received investigational products (200 mg TFG) twice per day for 8 weeks at least 30 minutes after food intake

Patients who received placebo twice per day for 8 weeks at least 30 minutes after food intake

Hypogonadism

TFG capsules were prepared using extracts from Trigonella foenum-graecum seed and Lespedeza cuneata. During the study period, two capsules were taken daily for 8 weeks.

TFG capsules (200 mg /capsule)

During the study period, two capsules were taken daily for 8 weeks. Placebo and TFG capsules were identical in shape, color, and taste.

Placebo oral capsule

Department of Urology, Pusan National University Hospital

Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS

Efficacy and Safety of a Mixed Extract of Fenugreek Seed and Lespedeza Cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-blind, Placebo-Controlled Clinical Trial

phytic acid/neoplasms

Effect of Phytin on Human Gut Microbiome (EPoM)

Efect of Quinoa and Flaxseed in Cititoxicity and Glicemic Control in Metabolic Syndrome Patients

Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS

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