Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Rice Germ
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obesity (BMI 30-40 kg/m2) age 50-65 menopause sedentary women and non-smoking, women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume) women who agreed not to take part in any other weight loss program Exclusion Criteria: evidence of heart, kidney or liver disease women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder taking any medications for weight loss control of cholesterol and triglycerides for anti-inflammatory purposes pregnancy lactating Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis antibiotic use in the last three months probiotic/prebiotic treatment in the last four weeks.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>an isocaloric wheat germ-based supplement | Combination Product: Placebo<br>* 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<br>|
| Active Comparator: Rice Germ<br> | Dietary Supplement: Rice Germ<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body composition | free fat mass (g), fat mass (g), visceral abdominal tissue (g) | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rice Germ, Body composition, Amino acids