Brown Seaweed Extract on Glycemic Control and Body Weight
Fjalë kyçe
Abstrakt
Përshkrim
Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.
The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on blood glucose measured 2 hours after an oral glucose tolerance test (OGTT) in overweight insulin-resistant men and women.
The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention. More specifically, the investigators aim to evaluate the effects of supplementation combined with weight loss on other markers of glucose metabolism (fasting plasma glucose, glucose and insulin response during OGTT, insulin sensitivity measurement parameters and insulin secretion during OGTT), lipid profile, blood pressure and metabolic syndrome criteria.
The investigators expect that InSea2® lowers the high levels of blood glucose and insulin observed 2 hours after a meal in overweight insulin-resistant human subjects.
Datat
| Verifikuar së fundmi: | 12/31/2018 |
| Paraqitur së pari: | 03/05/2017 |
| Regjistrimi i vlerësuar u dorëzua: | 03/05/2017 |
| Postuar së pari: | 03/08/2017 |
| Përditësimi i fundit i paraqitur: | 01/07/2019 |
| Përditësimi i fundit i postuar: | 01/09/2019 |
| Data e fillimit të studimit aktual: | 11/30/2016 |
| Data e vlerësuar e përfundimit primar: | 06/30/2018 |
| Data e vlerësimit të përfundimit të studimit: | 11/30/2019 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Dietary Supplement: InSea2
Dietary Supplement: Placebo
Faza
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| Experimental: InSea2 2 capsules/day of InSea2 administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) | Dietary Supplement: InSea2 Daily supplement: 2 capsules of InSea2 |
| Placebo Comparator: Placebo 2 capsules/day of Placebo administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) | Dietary Supplement: Placebo Daily supplement: 2 capsules of Placebo |
Kriteret e pranimit
| Moshat e pranueshme për studim | 18 Years Për të 18 Years |
| Gjinitë e pranueshme për studim | All |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | Inclusion Criteria: - overweight (BMI > 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men) - fasting insulin ≥ 60 pmol/L) - Impaired fasting glycemia with or without impaired glucose tolerance - HbA1c between 5.6 and 6.4 - non-smoking - stable weight in the past 3 months Exclusion Criteria: - diabetes - chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension) - taking drugs that could affect glucose or lipid metabolism or weight and appetite - taking dietary supplements or natural health products that could affect glucose, lipid, weight or appetite - major surgery 3 months prior to the study - past surgery of the digestive system - pregnancy - fish, seafood or iodine allergy |
Rezultati
Masat Kryesore të Rezultateve
1. Change in glucose metabolism [at baseline and at the end of the intervention (12 week)]
Masat dytësore të rezultateve
1. Change in insulin secretion [at baseline and at the end of the intervention (12 week)]
2. Change in body weight [at baseline and at the end of the intervention (12 week)]
3. Change in body lean mass distribution [at baseline and at the end of the intervention (12 week)]
4. Change in body fat mass distribution [at baseline and at the end of the intervention (12 week)]
