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

NCT ID: NCT04695418

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2019-12-27

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

an isocaloric wheat germ-based supplement

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Rice Germ

Group Type: ACTIVE_COMPARATOR

Rice Germ

Intervention Type: 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

Interventions

Rice Germ

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda di Servizi alla Persona

Pavia, , Italy

Countries

Italy

Other Identifiers

1402/22052019

Identifier Type: -

Identifier Source: org_study_id