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Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | an isocaloric wheat germ-based supplement |
|
| Rice Germ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice Germ | Dietary Supplement | The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of body composition | free fat mass (g), fat mass (g), visceral abdominal tissue (g) | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of amino acid profiles | aspartic acid, glutamic acid, alanine, arginine, asparagine, cysteine, citrulline, phenylalanine, glycine, glutamine, isoleucine, histidine, methylhistidine, methionine, ornithine, serine, tyrosine, threonine, tryptophan, valine (micromol/L) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona | Pavia | 27100 | Italy |
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| Placebo | Combination Product | An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks |
|
total serum cholesterol, triacylglycerol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A, apolipoprotein B, glucose, prealbumin, iron, uric acid, creatinine, electrolytes (mg/dl) |
| Baseline and 4 weeks |
| Change of biochemical metabolic parameters | total proteins (g/dl) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters | transaminase alanine aminotransferase, aspartate aminotransferase (IU/L) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters | gamma glutamyl transferase, lipase and amylase (U/L) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters | Homocysteine (micromol/L) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters | Vitamin D and folic acid (ng/mL) | Baseline and 4 weeks |
| Change of biochemical metabolic parameters | Vitamin B12 (pg/ml) | Baseline and 4 weeks |
| Change of inflammation markers | C- Reactive protein (mg/dl) | Baseline and 4 weeks |
| Change of insulin resistance | Homeostasis Model Assessment (HOMA) index | Baseline and 4 weeks |
| Change of satiating capacity | Haber score (point scale) | Every day for 4 weeks |
| Change of anthropometric measures | weight (kg) | Baseline and 4 weeks |
| Change of anthropometric measures | Body mass index (Kg/m2) | Baseline and 4 weeks |
| Change of anthropometric measures | calf circumference, waist circumference, arm circumference, hip circumference (cm) | Baseline and 4 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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