An interventional study of Flaxseed and Dietary plan in Prediabetic State, sponsored by Centro Universitario de Ciencias de la Salud, Mexico. Status unknown at 1 site in Mexico. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Centro Universitario de Ciencias de la Salud, Mexico · Not applicable, Interventional, and Treatment
Prediabetes is the term used to describe the condition where blood glucose level is higher than normal but lower than the diagnosis criteria of type 2 diabetes mellitus (T2DM). This condition confers a high risk for the development of T2DM and other diseases. Prediabetes could be reversible with lifestyle modifications, which include medical-nutrition therapy. Within these modifications, a healthy diet high in fiber and sources of alpha-linolenic acid is recommended. Flaxseed is a seed that is considered a functional food because it can provide health benefits due to its high content of fiber, alpha-linolenic acid, and lignans, these components could improve glycemic control in prediabetes patients by different mechanisms. The purpose of this study is to assess the effect of flaxseed on glycemic control in prediabetic adults.
Prediabetes is a condition that increases the risk of T2DM and other diseases, its prevalence increases year after year despite being a reversible condition through lifestyle changes, diet, and medication. Therefore, it is important to find new strategies that, together with the known treatments, help to improve glycemic control in people with prediabetes and thus their risk of developing TDM2. Among these strategies may be the consumption of flaxseed, one of the main sources of alpha-linolenic acid (ALA), an omega-3 fatty acid, lignans, and fiber.
This open-label randomized clinical trial will include, prior informed consent, 96 men and women with prediabetes, subjects will be allocated in two groups, the intervention group or the control group. The intervention group will receive 30 g per day of ground flaxseed dissolved in water, (15 g in the morning and 15 g in the night), they will also be provided with a dietary plan. The Control group will not receive any supplementation, only a dietary plan controlled in alpha-linolenic acid.
The intervention will last 12 weeks; during this time, all patients will be scheduled every 2 weeks for follow-up visits. During the follow-up visits, subjects will be evaluated for changes in gastrointestinal symptoms, and adherence to supplementation, which will be assessed by a daily record, and the return of empty or unopened bags of flaxseed.
Every month, all subjects will undergo anthropometric, clinical, dietary, and biochemical evaluations that include measurements of body weight, body composition, waist, and hip circumferences, blood pressure, physical activity, quality of food intake, dietary intake, fasting plasma glucose, hemoglobin A1C, insulin, LDL-C, HDL-C, triglycerides, and total cholesterol; an oral glucose tolerance test will be performed at baseline and the end of the study to each subject.
At the end of the study, the obtained information will be shared with the scientific community to provide a possible food-based strategy for prediabetic adults in addition to the already known prediabetes treatment. All participants of the study will be beneficiated with free nutritional, anthropometric, and biochemical assessments.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 96 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Centro Universitario de Ciencias de la Salud, Mexico is the lead sponsor of 27 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 g of ground flaxseed daily and a dietary plan
Other: Flaxseed
Dietary plan controlled in alpha-linolenic acid consumption
Other: Dietary plan
A total of 30 g of ground flaxseed per day divided into two portions of 15 grams each, subjects will be asked to take 15 g in the morning and 15 g in the night dissolved in 400 ml of water. They will receive a dietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates.
Dietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates, controlled consumption of alpha-linolenic acid (no more than 6.8 g/day, the amount provided by 30 g of flaxseed).
Fasting plasma glucose
Changes in plasma glucose concentration after the intervention (mg/dL)
Time frame: 12 weeks
2h-plasma glucose
Changes in 2h-plasma glucose concentration after an oral glucose tolerance test after the intervention (mg/dL)
Time frame: 12 weeks
Hemoglobin A1C
Changes in hemoglobin A1C after the intervention (%)
Time frame: 12 weeks
Insulin
Changes in insulin concentration after the intervention (mUI/L)
Time frame: 12 weeks
Insulin resistance
Changes in insulin resistance after intervention assessed by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), calculated using insulin and fasting plasma glucose concentrations
Time frame: 12 weeks
Lipid profile
Changes in total cholesterol, HDL-C, LDL-C, and triglycerides concentrations after the intervention (mg/dL)
Time frame: 12 weeks
Body Weight
Changes in body weight after the intervention (kg)
Time frame: 12 weeks
Body composition
Changes in body fat and muscle percentage after the intervention (%)
Time frame: 12 weeks
Waist and hip circumferences
Changes in waist and hip circumferences after the intervention (cm)
Time frame: 12 weeks
Blood pressure
Changes in systolic and diastolic blood pressure after the intervention (mmHg)
Time frame: 12 weeks
Physical activity level
Changes in total physical activity in METs-min/week assessed by the International Physical Activity Questionnaire - Short Form after the intervention
Time frame: 12 weeks
Food intake quality
Changes in food intake quality after the intervention assessed by the Mini-Survey to Evaluate Food Intake Quality (Mini-ECCA v.2)
Time frame: 12 weeks
Dietary ingestion
Changes in carbohydrate, protein, and fat ingestion after the intervention (g)
Time frame: 12 weeks
Stool classification
Changes in stool consistency will be assessed with The Bristol Stool Form Scale (BSFS) after the intervention. BSFS classifies stool into one of 7 stool types ranging from type 1 (hard lumps) to type 7 (watery), stool types 1 and 2 will be considered as constipation, stool types 5, 6, and 7 as diarrhea, and Stool types 3 and 4 as normal
Time frame: 12 weeks
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Centro Universitario de Ciencias de la Salud, Mexico